OPTRELL D140901Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10846835023015), received between Aug 17, 2022 and Sep 14, 2026 — classified as 7 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (9 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026Patient Device Interaction Problem

  Patient problems: Cardiac Tamponade

  MAUDE report 50763117 ↗
• MalfunctionAug 13, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH AN OPTRELL AND THE CATHETER BECAME CAUGHT ON THE ON THE ABBOTT SUPREME QUAD CATHETER. IT WAS REPORTED THAT AFTER MAPPING THE ACCESSORY PATHWAY AND ATTEMPTING TO PULL THE OPTRELL CATHETER OUT OF THE BODY, THE OPTRELL CATHETER BECAME CAUGHT ON THE ABBOTT SUPREME QUAD CATHETER. THE CALLER REPORTED THAT THE OPTRELL CATHETER MADE IT INTO THE SHORT SHEATH BUT THE ABBOTT SUPREME QUAD CATHETER FOLDED OVER ON ITSELF AND BECAME STUCK INSIDE OF THE SHORT SHEATH WITH THE OPTRELL CATHETER. THE ISSUE WAS CONFIRMED ON FLUORO. AN INTERVENTIONAL RADIOLOGIST WAS CALLED IN AFTER MONITORING THE ISSUE ON FLUORO AND THE ELECTROPHYSIOLOGY (EP) PHYSICIAN WAS ABLE TO PULL THE SHORT SHEATH OUT TO EXPOSE THE OPTRELL CATHETER AND THE ABBOTT SUPREME QUAD CATHETER. THE CALLER REPORTED THAT THE OPTRELL CATHETER WAS THEN CUT TO FREE IT FROM THE ABBOTT SUPREME QUAD CATHETER. THE ABBOTT SUPREME QUAD CATHETER WAS CUT IN HALF AND ONE PART OF THE ABBOTT SUPREME QUAD CATHETER WAS PULLED FROM OPTRELL ACCESS AND THE OTHER PART WAS PULLED FROM THE ABBOTT SUPREME QUAD ACCESS. THE PROCEDURE WAS CONTINUED AND COMPLETED. THE CALLER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22801301 ↗
• MalfunctionSep 16, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC DEEP VEIN THROMBOSIS (IDVT) ABLATION PROCEDURE WITH A OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND THE IRRIGATION PUMP THAT WAS CONNECTED TO THE CATHETER BEGAN TO ALERT. THE OPTRELL WAS REMOVED FROM THE PATIENT. THE PHYSICIAN THEN NOTED THAT THE CATHETER WAS COMPLETELY OCCLUDED AND NO IRRIGATION WAS FLOWING THROUGH THE CATHETER. THE MEDICAL TEAM EXCHANGED THE CATHETER FOR A NEW OPTRELL AND THE ISSUE WAS RESOLVED. THE CASE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20225868 ↗
• MalfunctionSep 3, 2024Coagulation in Device or Device Ingredient; Display or Visual Feedback Problem; Coagulation in Device or Device Ingredient; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING A RESEARCH PROCEDURE, WHEN CREATING MAPS OF AN EQUINE HEART, THE OPTRELL CATHETER WOULD INTERMITTENTLY NOT DISPLAY ALL THE SPLINES ON THE CARTO 3 SYSTEM, WHILE MAPPING A HORSE'S RIGHT ATRIUM. THE SYSTEM WOULD ONLY DISPLAY AND MAP FROM THE PROXIMAL POLES. THERE WERE NO ERRORS ON THE CARTO 3 SYSTEM AND THE CATHETER WAS WITHIN THE MAPPING ZONE. THE CARTO DISPLAYED A SOLID MATRIX OF THE CHAMBER OF INTEREST. THE OPTRELL CATHETER HAD TO BE REMOVED OFTEN TO CLEAR BLOOD CLOTS AND VISCOUS FILM OFF THE CATHETER. THE ACTIVATED CLOTTING TIME WAS OVER 600. IT WAS DETERMINED THAT THE CLOTS AND VISCOUS FILM WAS INTERRUPTING ADVANCED CATHETER LOCATION AND CATHETER VISUALIZATION. NO FURTHER ACTION WAS NEEDED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20127012 ↗
• InjuryJun 26, 2024Entrapment of Device; Patient Device Interaction Problem; Entrapment of Device; Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: USMAN BHATTI, ETHAN HACKER, JONATHAN M. BURNETT, SUNNY S. PO. (MAY 2024). DEER STUCK IN A FENCE; ENTRAPMENT OF HIGH-DENSITY GRID MAPPING CATHETER (OPTRELL) IN MITRAL SUBVAVLVULAR APPARATUS. HEART RHYTHM SOCIETY. PO-02-027. HTTPS://DOI.ORG/10.1016/J.HRTHM.2024.03.907. OBJECTIVE/METHODS/STUDY DATA: BACKGROUND: A 55 YEAR OLD MALE WITH ISCHEMIC CARDIOMYOPATHY WAS REFERRED TO ELECTROPHYSIOLOGY LAB FOR VT ABLATION. A NOVEL GRID CATHETER, OPTRELL (BIOSENSE WEBSTER, CA) WAS USED TO MAP LV VIA RETRO-AORTIC APPROACH. OBJECTIVE(S): FIRST KNOWN CASE OF ENTRAPMENT OF THE OPTRELL CATHETER IN THE MITRAL APPARATUS. ADDITIONALLY WE DESCRIBE OUR MULTI-MODALITY APPROACH TO RESCUE THE SITUATION AND AVOID EMERGENT SURGERY. METHOD(S): WHILE MAPPING THE LV, THE CATHETER BECAME DIFFICULT TO MANIPULATE, WE NOTICED NARROWING OF THE SPLINES AROUND THE MIDDLE LIKE IN A NOOSE. ICE AND FLUOROSCOPY VERIFIED THIS CONCERN. GENTLE ROTATION, ADVANCEMENT AND RETRACTION FAILED TO FREE THE CATHETER. ATTEMPT TO USE ABLATION CATHETER VIA TRANSSEPTAL TO PUSH THE OPTRELL APICALLY FAILED. TEE SHOWED CATHETER ENTANGLED IN THE CHORDAE

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 19618157 ↗
• MalfunctionJun 24, 2024Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRICULAR TACHYCARDIA PROCEDURE WITH AN OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED AN ELECTRODE PARTIALLY LIFTED. INITIALLY IT WAS REPORTED THAT THE POTENTIAL OF THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY 1-2 WAS NOT DISPLAYED. ELECTRICAL POTENTIAL LOSS OCCURRED. THE ISSUE OCCURRED WHEN THE CATHETER WAS CONNECTED, WHEN INSERTING THE CATHETER INTO THE CARDIAC CAVITY. IN INTRACARDIAC ONLY, BOTH CARTO 3 AND LAB, THE CATHETER WAS IN THE PATIENT¿S BODY AT THE TIME OF THE NOISE. THE CATHETER WAS REPLACED. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 27-MAY-2024, AN ELECTRODE WAS DAMAGED. THE ELECTRODE WAS OBSERVED DENTED AND PARTIALLY LIFTED; NO INTERNAL COMPONENTS WERE EXPOSED. THE EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF AN ELECTRODE PARTIALLY LIFTED ON (B)(6) 2024 AND HAVE ASSESSED THIS RETURNED CONDITION AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19602636 ↗
• InjuryMay 15, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR REENTRANT TACHYCARDIA/WOLFF-PARKINSON-WHITE (AVRT/WPW) ABLATION WHICH INCLUDED THE USE OF OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY, AND THE PATIENT EXPERIENCED PERICARDIAL EFFUSION THAT REQUIRED PERICARDIOCENTESIS AND PROLONGED HOSPITALIZATION. DURING THE PROCEDURE, THE PATIENT DEVELOPED A PERICARDIAL EFFUSION. THIS WAS OBSERVED BY A PRESSURE DROP AND CONFIRMED BY IMAGING WITH AN INTRACARDIAC ULTRASOUND CATHETER. A PERICARDIOCENTESIS WAS PERFORMED IN WHICH AN UNKNOWN AMOUNT OF BLOOD WAS REMOVED FROM THE PERICARDIAL SPACE. THE PATIENT WAS STABILIZED AND WAS TRANSFERRED TO THE CRITICAL CARE UNIT (CCU) FOR RECOVERY. THE EVENT IS BEING CONSERVATIVELY REPORTED UNDER THE OPTRELL MAPPING CATHETER UNTIL FURTHER INFORMATION ABOUT THE PROCEDURE OR EVENT IS PROVIDED.

  Patient problems: Cardiac Tamponade

  MAUDE report 19326159 ↗
• MalfunctionMay 15, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) PROCEDURE WITH A OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND IT BECAME OCCLUDED DURING USE IN THE PATIENT. THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY LUMEN BECAME OCCLUDED DURING USE IN THE PATIENT, THOUGH IT WAS BEING IRRIGATED WITH HEPARINIZED SALINE AT A KVO RATE. THEY REMOVED THE CATHETER, ATTEMPTED TO FLUSH IT MANUALLY BUT IT WAS COMPLETELY OCCLUDED. THEY EXCHANGED THE CATHETER TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE SUSPECTED DEVICE FOR THE REPORTED ISSUE WAS THE CATHETER. ISSUE WAS DISCOVERED WITH FLUSHING THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY USING A SYRINGE PRIOR TO CONNECTING TO A PUMP. NO ERROR ON THE PUMP. THEY REPLACED THE CATHETER WITH NO ISSUE. THEY DID NOT UTILIZE THE GENERATOR AT ALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19323220 ↗
• MalfunctionMay 6, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE ATRIAL CONTRACTION CARDIAC ABLATION PROCEDURE WITH A OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND IT COULD NOT ADVANCE THROUGH THE SHEATH. THE PHYSICIAN DESCRIBED THE HEAD OF THE OPTRELL AS "MANGLED" AFTER REMOVING IT FROM THE SHEATH. THERE WERE NO EXPOSED WIRES OR SHARP PORTIONS NOTED. THE PHYSICIAN WAS UNABLE TO DETERMINE IF THE OPTRELL WAS DAMAGED PRIOR TO ENTERING THE SHEATH. THE OPTRELL CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19251414 ↗
• MalfunctionMar 5, 2024Contamination; Contamination

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED THAT THERE WAS A WHITE MATERIAL WAS FOUND TRAPPED IN THE ELECTRODES. AN ANALYSIS WAS PERFORMED AND DETERMINED THAT THE WHITE MATERIAL'S COMPOSITION WAS PRINCIPALLY COMPOSED OF POLYSTYRENE BASE MATERIAL. THE ORIGIN OF THIS MATERIAL IS UNKNOWN. DURING THE PROCEDURE ITSELF, THE OPTRELL WAS INSERTED INTO THE PATIENT'S BODY, AND MAPPING OF THE RIGHT ATRIUM WAS PERFORMED. THE OPTRELL SPINES WERE NOT DISPLAYED IN THE MAPPING PHASE. RESET VISUALIZATION WAS PERFORMED AND THE CABLE WAS REPLACED. STUDY WAS EXIT, AND RELOADING WAS PERFORMED BUT THE ISSUE DID NOT RESOLVE. THE ISSUE WAS RESOLVED BY REPLACING THE OPTRELL TO ANOTHER NEW ONE. TISSUE LIKE CARDIAC MUSCLE WAS ATTACHED TO THE OPTRELL'S TIP. THE PROCEDURE WAS THEN COMPLETED, AND WHEN THE SECOND OPTRELL WAS REMOVED, SIMILAR TISSUE WAS IDENTIFIED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18839682 ↗
• InjuryFeb 26, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ISCHEMIC VENTRICULAR TACHYCARDIA (ISVT) ABLATION PROCEDURE WITH AN OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND THE PATIENT EXPERIENCED PERICARDIAL EFFUSION THAT REQUIRED PERICARDIOCENTESIS. A PERICARDIAL EFFUSION WAS DIAGNOSED VIA INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER DURING MAPPING OF THE LEFT VENTRICLE (LV). A PERICARDIOCENTESIS WAS PERFORMED BY THE PHYSICIAN. THE PATIENT WAS STABLE AT THE TIME OF THE CALL. THE PATIENT WAS SENT FOR OBSERVATION. ADDITIONAL INFORMATION WAS LATER RECEIVED INDICATING A TRANSSEPTAL PUNCTURE WAS PERFORMED. NO ABLATION WAS PERFORMED. NO ERROR MESSAGES OBSERVED ON BWI EQUIPMENT DURING THE PROCEDURE. PATIENT WAS REPORTED TO BE IMPROVED.

  Patient problems: Cardiac Tamponade

  MAUDE report 18780101 ↗
• MalfunctionJan 19, 2024Obstruction of Flow; Material Integrity Problem; Obstruction of Flow; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILATION (AFIB) PROCEDURE WITH AN OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND AN IRRIGATION ISSUE (USED IN THE PATIENT) OCCURRED. DURING THE PROCEDURE, AS THEY WERE FINISHING USING THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY, THE PHYSICIAN STATED THEY HEARD THE IRRIGATION FOR THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY BREAK. AT THIS POINT, THEY WERE FINISHED WITH THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY, SO THEY REMOVED IT FROM THE PATIENT'S BODY AND CONTINUED WITH THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE PHYSICAL IRRIGATION PORT BROKE. THE IRRIGATION PORT BROKE WAS ASSESSED AS NON MDR REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, WAS REMOTE. THE IRRIGATION ISSUE (USED IN THE PATIENT) WAS ASSESSED AS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18543338 ↗
• MalfunctionJan 9, 2024Coagulation in Device or Device Ingredient; Device Contamination with Body Fluid; Coagulation in Device or Device Ingredient; Device Contamination with Body Fluid

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A QDOT MICRO¿ CATHETER AND A OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND BOTH CATHETERS RESULTED WITH CHAR. DURING THE PROCEDURE, THE OUTPUT POWER SUPPRESSION WAS NOT APPLIED MUCH. BULL¿S EYE WORKED NORMALLY. THE PROCEDURE WAS COMPLETED AS IT WAS. THE PATIENT EXITED THE ROOM AS USUAL. AFTER THE PROCEDURE WAS COMPLETED, THE QDOT MICRO CATHETER AND THE OPTRELL WERE PULLED OUT FROM THE PATIENT¿S BODY. THEN, IT WAS FOUND THAT CHAR WAS ATTACHED ON THOSE TWO CATHETERS. CHAR WAS ATTACHED NEAR THE PROXIMAL ELECTRODE AND WAS NOT ATTACHED ON THE TIP OF THE CATHETER. ABLATION COULD BE PERFORMED NORMALLY, AND THE IRRIGATION FLOW WERE ADJUSTED AUTOMATICALLY BY THE NGEN. THE PATIENT WAS ANTICOAGULATED. HEPARINIZED NORMAL SALINE WAS USED. THERE WAS NO IMPACT ONTO THE PATIENT. DURING THE PROCEDURE, THE OUTPUT POWER SUPPRESSION WAS NOT APPLIED MUCH. BULL¿S EYE WORKED NORMALLY. THE PROCEDURE WAS COMPLETED AS IT WAS. THE PATIENT EXITED THE ROOM AS USUAL. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PHYSICIAN DID NOT CONSIDER THE CHAR TO BE EXCESSIVE BUT MENTIONED THAT THERE WERE SOME RISK TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18480639 ↗
• InjuryDec 13, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA ABLATION PROCEDURE USING AN OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY. DURING THE MAPPING PHASE, THE PATIENT EXPERIENCED A CARDIAC PERFORATION THAT REQUIRED A PERICARDIOCENTESIS. FIRST, A SOUNDSTAR CATHETER SENSOR ERROR 6150 DISPLAYED ON THE CARTO 3. THE ULS CABLE AND CATHETER CONNECTIONS WERE RESEATED WITHOUT RESOLUTION. THE CATHETER WAS REPLACED AND THE ISSUE RESOLVED. AFTER AN HOUR OR LESS THEN, THE 6150 ERROR REAPPEARED BUT THEY DID NOT HAVE TIME TO TROUBLESHOOT FURTHER. IN ADDITION, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CARDIAC PERFORATION THAT RESULTED IN A PERICARDIAL EFFUSION. THE PHYSICIAN WAS ADJUSTING THE SOUNDSTAR CATHETER AND DISCOVERED THE EFFUSION. CONFIRMED THROUGH ECHO AND OTHER SPECIALISTS. AFTER, THE EFFUSION GREW AND THEY STARTED MONITORING IT, THEY DID A ¿TAP¿ PERICARDIOCENTESIS. THE SMARTTOUCH SF ABLATION CATHETER WAS IN USE. NO ABLATION WAS PERFORMED AND THE ARRHYTHMIA WAS NEVER INDUCED. THE LAST KNOWN PATIENT STATUS WAS STABLE PER THE INITIAL CALL. ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT REQUIRED PROLONGED HOSPITALIZATION BECAUSE THE NEEDLE USED TO DO "THE

  Patient problems: Cardiac Perforation

  MAUDE report 18320272 ↗
• MalfunctionNov 1, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) - PAROXYSMAL ABLATION PROCEDURE WITH AN OPTRELL MAPPING CATHETER. THE OPTRELL WAS USED SUCCESSFULLY IN THE LEFT ATRIUM THROUGH AN 8.5 GUIDING SHEATH WITHOUT ISSUE. THE SHORT SHEATH WAS ONLY USED TOWARD THE END OF THE CASE, WHEN THE PHYSICIAN INSERTED THE OPTRELL INTO THE RIGHT ATRIUM TO CONFIRM ISTHMUS CONDUCTION BLOCK. WHILE USING THE OPTRELL CATHETER DIRECTLY THROUGH A SHORT, PINNACLE 9 FR. FEMORAL ACCESS SHEATH, THE CATHETER WAS NOT ABLE TO BE REMOVED FROM THE SHEATH, AS THE SHEATH TIP BUCKLED AND BECAME DAMAGED. THE CATHETER COULD NOT BE WITHDRAWN COMPLETELY, SO THE SHEATH AND CATHETER HAD TO BE REMOVED SIMULTANEOUSLY, WITH THE SPLINES UNGUARDED THROUGH THE FEMORAL ACCESS SITE. THE MEDICAL TEAM WAS ABLE TO REMOVE THE CATHETER. THERE WAS NO OPTRELL CATHETER DAMAGE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18052019 ↗
• MalfunctionOct 4, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH AN OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED THE TRANSITION OF THE TIP WITH THE SPLINES WAS BROKEN EXPOSING INTERNAL PARTS. IT WAS INITIALLY REPORTED THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY WOULD NOT ADVANCE INTO THE SL1 ABBOTT SHEATH. CALLER STATED THE PHYSICIAN HAD TO USE A DIFFERENT TYPE/BRAND OF SHEATH IN ORDER TO ADVANCE THE CATHETER. WHEN THE SHEATH AND THE CATHETER WAS REPLACED, THE ISSUE RESOLVED. THE CUSTOMER¿S REPORTED ISSUE OF RESISTANCE WITH THE SHEATH IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE AN INCREASED POTENTIAL FOR PATIENT INJURY IS REMOTE. ON 13-SEP-2023, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THE TRANSITION OF THE TIP WITH THE SPLINES WAS BROKEN EXPOSING INTERNAL PARTS. THIS FINDING WAS REVIEWED AND ASSESSED AS AN MDR REPORTABLE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17870725 ↗
• MalfunctionSep 25, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A PATIENT WITH DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH AN OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND WHEN TAKING THE CATHETER OUT OF THE BODY RESISTANCE WAS MET. IT WAS REPORTED THAT WHEN TAKING THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY CATHETER OUT OF THE BODY, HE WAS MEETING SOME RESISTANCE AT THE INFERIOR VENA CAVA (IVC) LEVEL ON CARTO WHEN REMOVING THE CATHETER, HOWEVER, HE ELECTED TO ADVANCE AND THEN WAS ABLE TO WITHDRAW AFTER A COUPLE OF TIMES ADVANCING TO THE SUPERIOR VENA CAVA (SVC) VIA CATHETER VISUALIZATION ON THE CATHETER. THE CATHETER WAS MOVED SUPERIOR TO INFERIORLY SEVERAL TIMES AND THE CATHETER WAS ABLE TO BE WITHDRAWN FROM THE BODY. THEN IMPLANTED AICD WAS THEN INTERROGATED AND THE ATRIAL LEAD WOULD NOT PACE. THE HEART WAS THEN X-RAYED AND THE ATRIAL LEAD WAS DISLODGED. THE PATIENT IS STABLE. A LEAD REVISION IS BEING SCHEDULED. THE PHYSICIAN DISCHARGED THE PATIENT THAT EVENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17808845 ↗
• MalfunctionSep 14, 2023Signal Artifact/Noise; Coagulation in Device or Device Ingredient; Signal Artifact/Noise; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ID VT  (IDIOPATHIC VENTRICULAR TACHYCARDIA) ABLATION PROCEDURE WITH A OPTRELL MAPPING CATHETER THERE WAS A LOT OF NOISE ON NEARLY EVERY ELECTRODE PAIRING OF THE CATHETER. THE CATHETER CABLE WAS REPLACED WITHOUT RESOLUTION. THE CATHETER WAS REMOVED AND THERE WAS CLOT ON THE CATHETER (TIP OF PADDLE). ACT (ACTIVATED CLOTTING TIME) WAS ABOVE 400 SECONDS. THE CATHETER WAS CLEANED AND REINSERTED AND THERE WAS NOISE ON ALL ELECTRODES. THE CATHETER WAS REMOVED AGAIN AND THERE WAS MORE CLOT NOTED (ALL OVER THE PADDLE). THE ACT HAD STILL EXCEEDED 400 SECONDS. THE ABLATION CATHETER WAS THEN INSERTED TO COMPLETE MAPPING. NO PATIENT CONSEQUENCES WERE REPORTED. THE NOISE IS NOT MDR-REPORTABLE. THE CLOTTING IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17750422 ↗
• MalfunctionSep 5, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ISOLATED SPLENIC VEIN THROMBOSIS (ISVT) ABLATION PROCEDURE WITH AN OPTRELL MAPPING CATHETER. DURING THE PROCEDURE, THE MEDICAL TEAM DISCOVERED THAT THE OPTRELL MAPPING CATHETER GOT ENTANGLED IN THE LEFT VENTRICLE (LV) AND THE POSTERIOR CAPILLARY CORDAE. THE MEDICAL TEAM USED THE TIMELINE FUNCTION ON THE CARTO 3 SYSTEM TO FOLLOW THE TIMELINE AND SUCCESSFULLY DISENTANGLE THE CATHETER. THE PATIENT SUFFERED NO INJURIES AND MAINTAINED STABILITY THROUGHOUT AND CONTINUED TO BE STABLE. NO PATIENT CONSEQUENCES WERE REPORTED. THE DEVICE ENTANGLEMENT IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17685866 ↗
• InjuryAug 3, 2023Entrapment of Device; Patient Device Interaction Problem; Entrapment of Device; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH AN OPTRELL MAPPING CATHETER WITH TRUE REF TECHNOLOGY. IT WAS REPORTED THAT DURING AN IDIOPATHIC VT CASE, A PERFORATION TO THE ILIAC ARTERY WAS NOTICED IN THE PATIENT. THE PHYSICIAN HAD DIFFICULTY GETTING ACCESS ARTERIALLY AND VENOUSLY IN THE GROIN AREA. THE PHYSICIAN WAS FINALLY ABLE TO GET VENOUS ACCESS, BUT WHEN THE PHYSICIAN HAD ADVANCED THE OPTRELL CATHETER ON THE ARTERIAL SIDE, IT WAS GETTING "STUCK." THE CONTRAST DYE WAS SHOT INTO THE PATIENT. THE PHYSICIAN NOTICED THAT THE CONTRAST DYE WAS NOT FLOWING PROPERLY. THE PATIENT'S BLOOD PRESSURE DROPPED. THE PATIENT CONTINUED TO BE MONITORED AND HOLD PRESSURE. A SURGEON WAS CALLED IN, AND THE PATIENT WAS TAKEN STRAIGHT TO GENERAL SURGERY. THEY COULD NOT CONFIRM WHAT MEDICAL INTERVENTION WAS PROVIDED TO THE PATIENT. THE PATIENT WAS STABLE AT THE TIME OF THE CALL. THE ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT IT WAS PROCEDURE AND/OR PATIENT CONDITION RELATED. THE PATIENT WAS TAKEN TO SURGERY FOR REPAIR OF THE VESSEL. THE OUTCOME O

  Patient problems: Perforation of Vessels

  MAUDE report 17455514 ↗
• MalfunctionJul 25, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (LEFT) ABLATION PROCEDURE WITH AN OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND THE CATHETER GOT STUCK IN PATIENT. IT WAS REPORTED BY THE CALLER, THE BWI REPRESENTATIVE, THAT DURING A PROCEDURE AN ADVERSE EVENT OCCURRED. THEY WERE PERFORMING A PREMATURE VENTRICULAR CONTRACTION (PVC) PROCEDURE AND THE OPTRELL CATHETER GOT STUCK AS THEY WERE TRYING TO PULL IT OUT AND REPLACE IT WITH THE ABLATOR. THE CALLER REPORTED THAT WHEN THEY WITHDREW THE CATHETER, THEY PULLED IT THROUGH THE AORTA, AND IT CAME OUT FINE, BUT IT HAD FOLDED BACK ON ITSELF AS THE PHYSICIAN WAS COMING DOWN THE ARTERY AND THEY COULD NOT GET IT OUT. THE CALLER REPORTED THAT THE PHYSICIAN "BROUGHT FLUORO DOWN AND NOTICED THE CATHETER WAS FOLDED BACK ON ITSELF." THE CALLER REPORTED THAT THEY TRIED MOVING THE SHEATH AND THE CATHETER, THEY TRIED WITHDRAWING THE SHEATH AND PULLING THE CATHETER OUT AND STILL COULD NOT MOVE IT. THE PHYSICIAN WAS NERVOUS TO USE FORCE AND THE PHYSICIAN CALLED FOR CT SUPPORT AND INTERVENTIONAL RADIOLOGY BACKUP. THE CALLER REPORTED THAT THEY FINALLY WERE ABLE TO PULL IT OUT AND IT FINALLY FOLDED BACK ON ITSELF. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17390398 ↗
• MalfunctionJun 22, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) PROCEDURE WITH AN OPTRELL CATHETER AND A MEDICAL DEVICE ENTRAPMENT ISSUE OCCURRED. DURING THE PROCEDURE, THE VIZIGO, OPTRELL, AND QUADRIPOLAR CATHETERS BECAME ENTANGLED. THE PHYSICIAN WAS ABLE TO MANUALLY MANEUVER THE CATHETERS AND RESOLVE THE ENTANGLEMENT. THE PROCEDURE CONTINUED. NO ADVERSE CONSEQUENCES TO THE PATIENT. DOCUMENTATION PURPOSES ONLY. NO CATHETERS ARE AVAILABLE FOR RETURN. NO REPLACEMENT CATHETERS OR FURTHER ACTIONS ARE BEING REQUESTED. ADDITIONAL INFORMATION WAS RECEIVED. THE DAMAGE DID NOT RESULT IN WIRES BEING EXPOSED. THE DAMAGE DID NOT RESULT IN ANY LIFTED OR SHARP RINGS. HE HAD DIFFICULTY TO REMOVE THE CATHETER BECAUSE IT WAS TANGLED WITH QUADRIPOLAR CATHETER. PICTURE PROVIDED. THE CATHETER WAS NOT PRE-SHAPED. THE EVENT WAS ASSESSED AS MDR REPORTABLE FOR A MEDICAL DEVICE ENTRAPMENT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17187302 ↗
• MalfunctionJun 8, 2023Contamination /Decontamination Problem; Material Twisted/Bent; Contamination /Decontamination Problem; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND A FOREIGN MATERIAL WAS FOUND ON THE DEVICE. IT WAS REPORTED THAT AFTER THE OPTRELL CATHETER WAS REMOVED FROM THE BODY, AFTER THE PROCEDURE, A KINK WAS NOTICED IN ONE OF THE SPLINES. THE CALLER ALSO REPORTED THAT ELECTRODE F2 HAD SOME FOREIGN DEBRIS ON IT. THE CALLER REPORTED THAT THE DEBRIS APPEARED TO BE "LINT" OR A SMALL PIECE OF METAL. THERE WAS NO RESISTANCE AND NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17088610 ↗
• MalfunctionJan 10, 2023Display or Visual Feedback Problem; Contamination /Decontamination Problem; Display or Visual Feedback Problem; Contamination /Decontamination Problem

  A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A OPTRELL CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB IDENTIFIED DURING MICROSCOPIC ANALYSIS THAT ELECTRODES A1 AND A2 WERE LIGHTLY LIFTED AND FOREIGN MATERIAL WAS FOUND UNDER THE ELECTRODES. THE FINDING WAS IDENTIFIED ON (B)(6) 2022. IT WAS REPORTED THAT THE SPLINES OF THE OPTRELL CATHETER WERE DISAPPEARING ON THE CARTO 3 SYSTEM. THE MEDICAL TEAM TRIED DISCONNECTING THE ULTRASOUND CATHETER WITH NO RESOLUTION. THEY TURNED OFF THE TRUEREF ELECTRODE WITH NO RESOLUTION. THEY RESET THE VISUALIZATION MATRIX AND THE ISSUE STILL REMAINED. AFTER REPLACING THE CATHETER CABLE, THE ISSUE PERSISTED. THERE WAS ALSO ISSUES WITH VISUALIZATION SO THE PHYSICIAN REQUESTED TO SWITCH TO THE OCTARAY CATHETER. NO OTHER ISSUES WERE REPORTED USING THE OCTARAY CATHETER. NO PATIENT CONSEQUENCES WERE REPORTED. VISUALIZATION ISSUE IS NOT MDR-REPORTABLE. FOREIGN MATERIAL IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16128811 ↗
• InjurySep 15, 2022Entrapment of Device; Patient Device Interaction Problem; Entrapment of Device; Patient Device Interaction Problem

  IT WAS REPORTED THAT AN UNKNOWN FEMALE PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH A SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER AND AN OPTRELL¿ MAPPING CATHETER WITH TRUEREF¿ TECHNOLOGY. THE OPTRELL AND SOUNDSTAR BECAME TANGLED AND THE PATIENT SUFFERED VASCULAR INJURY REQUIRING INTERVENTION. DURING A PVC CASE, THE PATIENT SUFFERED A VASCULAR INJURY. THE BWI COMPANY REPRESENTATIVE STATED THE OPTRELL CATHETER GOT ENTANGLED WITH THE ICE (INTRACARDIAC ECHOCARDIOGRAPHY) CATHETER. THEY WERE MOVING THRU THE ATRIUM AND THE ICE CATHETER WENT THRU ONE OF THE OPTRELL SPLINES. THEY KEPT TRYING TO PULL THE OPTRELL CATHETER AND EVENTUALLY THEY PULLED THE SHEATH OUT THAT THE OPTRELL CATHETER WAS IN. THE PROXIMAL PADDLE THEN GOT ENTRAPPED WITH THE SHAFT OF THE ICE CATHETER. AS THEY CONTINUED TO PULL THE OPTRELL, BOTH THE ICE CATHETER AND THE SHEATH IT WAS IN, WENT OUT OF THE VEIN AND INTO THE TISSUE. THE PATIENT STARTED BLEEDING FROM THE LARGE HOLE. A VASCULAR SURGEON WAS CALLED AND HE TOLD THEM TO PULL IT ALL OUT OF THE SKIN. THEY PULLED THE OPTRELL, THE SHAFT OF THE ICE CATHETER AND THE SHEATH OUT OF THE SKIN AND THEN CU

  Patient problems: Perforation of Vessels

  MAUDE report 15433555 ↗