Verrata Pressure Guide Wire 185cm 10185Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00845225002435), received between Dec 9, 2016 and May 28, 2021 — classified as 18 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Material Separation” (15 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2021Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT DURING A CORONARY PROCEDURE IN THE BODY POST NORMALIZATION AND PRE MEASUREMENT, THE MANUFACTURER'S GUIDE WIRE DISPLAYED NO PD PRESSURE IN THE IVUS IMAGE. RE-CALIBRATION WAS PERFORMED BY UNPLUGGING THE CONNECTOR FROM THE MANUFACTURER'S GUIDE WIRE, BUT THERE WAS NO CONNECTION BETWEEN PA AND PD. THE RETURNED DEVICE WAS VISUALLY AND MICROSCOPICALLY INSPECTED. THE SENSOR WAS RAISED ABOVE THE SENSOR HOUSING WITH A SHARP EDGE OBSERVED. DURING FUNCTIONAL TESTING, THE MANUFACTURER'S GUIDE WIRE FAILED THE ZERO TEST, THUS THE DRIFT TEST COULD NOT BE PERFORMED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE A SHARP EDGE ON THE SENSOR HOUSING HAS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11904776 ↗
• MalfunctionApr 11, 2019Material Separation; Material Separation

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER¿S POLICY. IT WAS REPORTED DURING A PLANNED DIAGNOSTIC CORONARY PROCEDURE THE PD CURVE DISAPPEARED ON THE MANUFACTURE¿S DEVICE BEFORE NORMALIZATION. ANOTHER SAME MANUFACTURE¿S PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THERE IS NO PATIENT INJURY. RADIAL ACCESS. BY REPORT, NO DAMAGE WAS OBSERVED TO THE DEVICE AND NO RESISTANCE WAS ENCOUNTERED. THE RETURNED DEVICE WAS VISUALLY AND MICROSCOPICALLY INSPECTED AND DAMAGE WAS OBSERVED. THE WIRE HAD MULTIPLE KINKS, THE SENSOR WAS BROKEN AND A PORTION OF THE PRESSURE SENSOR WAS MISSING. THE PROBABLE CAUSE OF THE DAMAGE COULD BE CAUSED BY ROUGH HANDLING OF THE DEVICE DURING PROCEDURE AS EVIDENCED IN THE SEVERAL BENTS IN THE DISTAL COIL. WE WERE UNABLE TO CONCLUSIVELY DETERMINE WHEN AND HOW THE DAMAGE OCCURRED. THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. THIS SUBMISSION IS BEING REPORTED BECAUSE THE SENSOR WAS MISSING FROM THE MANUFACTURE¿S DEVICE. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8507307 ↗
• MalfunctionFeb 15, 2019Material Separation; Material Separation

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER¿S POLICY. IT WAS REPORTED DURING A PLANNED DIAGNOSTIC CORONARY PROCEDURE THE TIP OF THE SENSOR WAS BROKEN. THERE IS NO PATIENT INJURY. BY REPORT, THE DEVICE WAS INTACT UPON REMOVAL FROM THE PATIENT. ANOTHER PRESSURE WIRE WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS DISCARDED AT THE FACILITY AND NOT RETURNED FOR ANALYSIS. THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. THIS PRODUCT PROBLEM IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION AS IT COULD NOT BE DETERMINED WHERE OR WHEN THE ALLEGED SEPARATION OCCURRED. THERE IS A POTENTIAL FOR HARM IF THE ALLEGED SEPARATION WERE TO RECUR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8344686 ↗
• InjuryDec 7, 2018Stretched; Insufficient Device Problem Information; Stretched; Insufficient Device Problem Information

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED, INSIDE THE BODY, AFTER NORMALIZATION, PRIOR TO MEASUREMENT, THE WIRE COULD NOT MOVE INSIDE THE CATHETER. THE WIRE COULD NOT PULL OUT ALONE, SO PULLED OUT WITH THE CATHETER AT THE SAME TIME FROM PATIENT. WHEN CHECKING THE WIRE, THERE WAS A COATING FRICTION. THIS EVENT IS BEING REPORTED BECAUSE THE MANUFACTURES DEVICE AND ANOTHER MANUFACTURER'S GUIDE CATHETER WERE REMOVED AS A SYSTEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8144721 ↗
• InjuryDec 3, 2018Deformation Due to Compressive Stress; Insufficient Device Problem Information; Deformation Due to Compressive Stress; Insufficient Device Problem Information

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. THIS FOLLOW-UP REPORT (# 1) IS BEING SUBMITTED TO PROVIDE INITIAL REPORTER INFORMATION, DEVICE ANALYSIS FINDINGS AND RELATED CODING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8123540 ↗
• MalfunctionOct 17, 2018Material Separation; Material Separation

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED, AFTER PERFORMING THREE (3) IFR MEASUREMENTS, THE AORTIC PRESSURE SIGNAL WAS LOST. VISUAL, MICROSCOPIC INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED ON THE RETURNED DEVICE. THE SENSOR WAS BROKEN AND THE DISTAL PORTION OF THE SENSOR WAS MISSING. THE DEVICE WAS NOT RECOGNIZED DURING TESTING. THE PROBABLE CAUSE OF THE REPORTED FAILURE IS AN ELECTRICAL ISSUE WITHIN THE DEVICE. THE PROBABLE CAUSE OF THE OBSERVED BROKEN AND MISSING DISTAL PORTION OF THE SENSOR COULD NOT BE CONCLUSIVELY DETERMINED BY THE INVESTIGATION. THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. THIS EVENT IS BEING REPORTED AS THERE IS A POTENTIAL FOR HARM IF THE EVENT WERE TO RECUR. A PIECE OF THE SENSOR IS MISSING AND IT CANNOT CONCLUSIVELY BE DETERMINED WHEN OR WHERE THE SEPARATION OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7976625 ↗
• InjuryAug 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A DIAGNOSTIC CORONARY PROCEDURE, INSIDE THE BODY AFTER NORMALIZATION AND PRIOR TO MEASUREMENT, THE USER FELT RESISTANCE AT THE LESION AND THE WIRE WAS STUCK. THE WIRE COULD BE REMOVED WITH MICROCATHETER AND NO DAMAGE WAS OBSERVED ON THE WIRE. THE PROCEDURE WAS COMPLETED WITH THE SUSPECT DEVICE. THERE WAS NO STATUS DECLINE, EVIDENCE OF AN INJURY. THIS ADVERSE EVENT IS BEING REPORTED BECAUSE ADDITIONAL INTERVENTION WAS REQUIRED TO REMOVE THE MANUFACTURE'S DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7835981 ↗
• InjuryAug 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED, DURING ADVANCEMENT OF THE MANUFACTURER'S DEVICE IT SLIPPED INTO ONE OF THE SIDEHOLES OF THE GUIDE CATHETER (GC, ANOTHER MANUFACTURER'S DEVICE). RETRACTION OF THE MANUFACTURER'S DEVICE WAS NOT POSSIBLE AS THE MANUFACTURER'S DEVICE WAS STUCK IN THE SIDEHOLE OF THE GC. THE PHYSICIAN REMOVED THE ENTIRE SYSTEM (GC ALONG WITH THE MANUFACTURER'S DEVICE) AND RESTARTED THE PROCEDURE WITH NEW EQUIPMENT. THIS EVENT IS BEING REPORTED BECAUSE THE MANUFACTURES DEVICE AND ANOTHER MANUFACTURER'S GUIDE CATHETER WERE REMOVED AS A SYSTEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7749573 ↗
• MalfunctionAug 1, 2018Fracture; Fracture

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED DURING A PLANNED DIAGNOSTIC CORONARY PROCEDURE, INSIDE THE BODY, BEFORE NORMALIZATION, THE USER TRIED TO FIX THE MANUFACTURER'S DEVICE AT (THE) USUAL POSITION IN THE CONNECTOR BUT IT COULD NOT BE CAUGHT. THE DEVICE WAS RECONNECTED BUT THE PROBLEM WAS NOT SOLVED. ADDITIONAL INFORMATION WAS PROVIDED, THE DEVICE HAD BEEN INSPECTED PRIOR TO THE PROCEDURE WITH NO VISIBLE DEFECTS OBSERVED. POST PROCEDURE, THE DEVICE WAS OBSERVED TO HAVE DAMAGE AT THE CONNECTION TO THE CONNECTOR. REPORTEDLY, NO PORTIONS OF THE DEVICE SEPARATED OR DETACHED WITHIN THE PATIENT. A SECOND OF THE SAME MAKE AND MODEL OF THE MANUFACTURER'S DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY AND NO ADVERSE EVENT. VISUAL AND MICROSCOPIC INSPECTION WERE PERFORMED ON THE RETURNED DEVICE. THE PROXIMAL CONDUCTIVE BAND AND ITS LOCKING CORE WERE SEPARATED AND MISSING. THE PROBABLE CAUSE OF THE REPORTED FAILURE WAS DAMAGED DURING USE, AS EVIDENCED BY THE MISSING PROXIMAL CONDUCTIVE BAND AND LOCKING CORE. MANIPULATION AND STRAIN ON THE DEVICE CAN CAUSE DAMAGE TO COMPONENTS AND RESULT IN THE REPORT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7741605 ↗
• InjuryJul 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED, INSIDE THE BODY, AFTER NORMALIZATION, PRIOR TO MEASUREMENT, THE MANUFACTURER'S DEVICE WAS STUCK AFTER CROSSING THE CALCIFIED LESION. THE MANUFACTURER'S DEVICE WAS RETRIEVED WITH USING A MICROCATHETER. ANOTHER MANUFACTURER'S DEVICE WAS ALTERNATIVELY USED AND THE PROCEDURE WAS COMPLETED. ACCESS LOCATION: RADIAL, VESSEL TORTUOUSITY: MODERATE. THIS EVENT IS BEING REPORTED BECAUSE ADDITIONAL INTERVENTION WAS REQUIRED; USE OF A MICROCATHETER TO REMOVE THE MANUFACTURES DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7726530 ↗
• MalfunctionJul 2, 2018Material Protrusion/Extrusion; Material Protrusion/Extrusion

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED DURING A PLANNED DIAGNOSTIC CORONARY PROCEDURE, INSIDE THE BODY, AFTER NORMALIZATION, PRIOR TO MEASUREMENT, RESISTANCE WAS MET. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT FOR SHAPING AGAIN, THE USER FOUND THE PROXIMAL COIL WAS STRETCHED. ADDITIONAL INFORMATION PROVIDED THE DEVICE HAD BEEN INSPECTED PRIOR TO THE PROCEDURE WITH NO VISIBLE DEFECTS OBSERVED. RESISTANCE WAS ENCOUNTERED WHEN CROSSING THE LESION. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, THE USER FOUND THAT THE WIRE TIP WAS STRETCHED BUT WAS NOT SEPARATED. A SECOND OF THE SAME MAKE AND MODEL OF THE MANUFACTURER'S DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. VISUAL AND MICROSCOPIC INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE DEVICE WAS VISUALLY AND MICROSCOPICALLY INSPECTED, DAMAGE WAS OBSERVED. THE DISTAL COIL WAS OBSERVED TO BE STRETCHED BUT WAS INTACT. THE CORE WIRE WAS TWISTED AND BROKEN. THE ENTIRETY OF THE CORE WIRE APPEARED TO BE PRESENT. THE INVESTIGATION WAS UNABLE TO VERIFY THE REPORTED RESISTANCE FAILURE AS THE DEVICE WAS DAMAGED. THE PROBABLE CAUSE FOR THE REPORTED STRETCH FAILURE IS DAMAGE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7656627 ↗
• MalfunctionJun 27, 2018Material Separation; Material Separation

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED, INSIDE THE BODY, AFTER NORMALIZATION, PRIOR TO MEASUREMENT, THE PD CURVE DISAPPEARED. ADDITIONAL INFORMATION PROVIDED, THE DEVICE WAS INSERTED INTO THE PATIENT ONCE. NO ADDITIONAL INTERVENTION WAS PERFORMED, THERE WAS NO PATIENT STATUS DECLINE NOR PATIENT INJURY. NO RESISTANCE WAS EXPERIENCED DURING THE PROCEDURE. NO DAMAGE WAS OBSERVED PRIOR TO THE PROCEDURE AND THE DEVICE IS REPORTED TO HAVE BEEN INTACT AND IN ONE PIECE UPON REMOVAL FROM THE PATIENT. A SECOND OF THE SAME MAKE AND MODEL OF THE MANUFACTURER'S DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. VISUAL AND MICROSCOPIC INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED ON THE RETURNED DEVICE. THE CORE WIRE WAS BROKEN AND A PORTION MISSING; NO CORE WIRE WAS OBSERVED PAST THE PRESSURE SENSOR HOUSING. A PORTION OF THE DISTAL COIL WAS MISSING. THE REMAINING DISTAL COIL WAS STRETCHED. THE PRESSURE SENSOR WAS INTACT. THE DEVICE PASSED ZERO TESTING. DRIFT TESTING WAS NOT PERFORMED SINCE THE WIRE WAS DAMAGED. THE PROBABLE CAUSE OF THE REPORTED SIGNAL/CONNECTION FAILURE COULD NOT BE DETERMINED. THE DEVICE PASSED ZERO TESTING AND

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7644142 ↗
• MalfunctionJun 22, 2018Material Separation; Material Separation

  IT WAS REPORTED, INSIDE THE BODY, AFTER NORMALIZATION, PRIOR TO MEASUREMENT, THE PD DRIFTED FROM PA MORE THAN 5 MMHG. THE WIRE WAS NORMALIZED SEVERAL TIMES BUT PD DRIFTED AGAIN. THE WIRE/CONNECTOR CABLE WERE RECONNECTED BUT THE PROBLEM WAS NOT SOLVED. ADDITIONAL INFORMATION PROVIDED THE DEVICE HAD BEEN INSPECTED PRIOR TO THE PROCEDURE WITH NO VISIBLE DEFECTS OBSERVED. NO RESISTANCE WAS ENCOUNTERED. IT WAS REPORTED BY THE USER THAT THE DEVICE WAS REMOVED FROM THE PATIENT AND APPEARED TO BE IN ONE PIECE AND INTACT. THE PROCEDURE WAS NOT COMPLETED WITH THE SUBJECT DEVICE. A SECOND OF THE SAME MAKE AND MODEL OF THE MANUFACTURES DEVICES WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. VISUAL AND MICROSCOPIC INSPECTION WERE PERFORMED ON THE RETURNED DEVICE. THE SENSOR WAS BROKEN AND THE DISTAL PORTION OF THE SENSOR WAS MISSING. USING A KNOWN GOOD CONNECTOR FROM THE LAB, THE WIRE WAS NOT RECOGNIZED DURING ZERO TESTING. DRIFT TESTING WAS NOT CONDUCTED AS THE MATCHING CONNECTOR WAS NOT RETURNED AND THE WIRE WAS NOT RECOGNIZED. THE PROBABLE CAUSE OF THE REPORTED DRIFT FAILURE COULD NOT BE DETERMINED DUE TO THE OBSERVED BROKEN SENSOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7630698 ↗
• InjuryJun 3, 2018Material Separation; Material Separation

  IT WAS REPORTED DURING A PLANNED DIAGNOSTIC CORONARY PROCEDURE, INSIDE THE BODY, AFTER IFR MEASUREMENT AT LAD, THE WIRE ACCIDENTALLY WENT INTO 2ND DIAGONAL BRANCH (D2) WHILE MANUFACTURES DEVICE ADVANCED TO DISTAL LAD. THE WIRE TIP WAS STUCK AND COULD NOT BE REMOVED. THE CONNECTOR WAS DETACHED, A MICROCATHETER WAS ADVANCED ALONG THE WIRE AND DELIVERED AT THE STUCK POINT. HOWEVER, THE MANUFACTURES DEVICE COULD NOT BE REMOVED AND THE RADIOPAQUE PORTION OF THE WIRE WAS FOUND TO BE STRETCHED AND SEPARATED. THE DISTAL COIL WAS STRETCHED TO THE SUBCLAVIAN ARTERY (SCA). GOOSE NECK SNARE WAS USED TO RETRIEVE THE SEPARATED WIRE. THE SNARE LOOP COULD BE ADVANCED AND GRAB THE WIRE AT THE SCA. THE GOOSE NECK SNARE COULD BE REMOVED TO LEFT CORONARY OSTIAL WITH THE SEPARATED WIRE PORTION, THE LOOP OF GOOSE NECK SNARE WAS SEIZED AND COULD BE REMOVED TO OUTSIDE THE BODY SUCCESSFULLY. THERE WAS NO PATIENT INJURY. VESSEL: STUCK IN LAD, VESSEL TORTUOSITY: MODERATE, CALCIFICATION: NONE. THIS EVENT IS BEING REPORTED BECAUSE THE DEVICE SEPARATED AND ADDITIONAL INTERVENTION WAS REQUIRED TO REMOVE THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7564055 ↗
• InjuryMay 24, 2018Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED, INSIDE THE BODY, AFTER NORMALIZATION, PRIOR TO MEASUREMENT, THE MANUFACTURE DEVICE COULD NOT CROSS THE LESION AT #6-7 OF LAD. THE USER TRIED TO MANIPULATE BUT THE TORQUE WAS NOT TRANSMITTED TO THE WIRE TIP AND THE MANUFACTURES DEVICE COULD NOT BE ROTATED. THE USER THOUGHT THAT THE MANUFACTURES DEVICE WAS STUCK AT SIDE DITCH OF THE DIAGNOSTIC CATHETER. RESISTANCE WAS MET WHEN REMOVING THE MANUFACTURES DEVICE FROM THE DIAGNOSTIC CATHETER AND IT COULD NOT BE MOVED BACK AND FORTH. BECAUSE THE USER THOUGHT THE MANUFACTURES DEVICE WOULD BE SEPARATED, THE USER USED ADDITIONAL DEVICES TO BE ABLE TO ADVANCE TO THE WIRE TIP AND THE MANUFACTURES DEVICE WAS FREED AND REMOVED WITHOUT ANY MISSING PARTS. VESSEL INFORMATION: LAD # 6 AND 7. VESSEL TORTUOSITY: NONE, % DS: 50~75% ON ANGIOGRAPHY. OTHER DEVICES IN USE: FUKUDADENSHI: DIAGNOSTIC CATHETER 4FR; MEDTRONIC: LAUNCHER 6F JL4.0; JAPAN LIFE LINE: GUIDELINER; KANEKA: MIZUKI; THIS EVENT IS BEING REPORTED BECAUSE ADDITIONAL INTERVENTION WAS USED TO REMOVE THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7543080 ↗
• MalfunctionMay 18, 2018Material Protrusion/Extrusion; Material Protrusion/Extrusion

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED DURING A PLANNED DIAGNOSTIC CORONARY PROCEDURE, OUTSIDE THE BODY BEFORE FIRST USE, DURING PREP/LOADING, THE PD CURVE WAS NOT DISPLAYED. PROCEDURE WAS ABORTED. THE WIRE WAS NOT ZEROED OR NORMALIZED. THERE WAS NO PATIENT INJURY. VISUAL AND MICROSCOPIC INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED ON THE RETURNED DEVICE. DAMAGE WAS OBSERVED ON THE DEVICE. THE PROXIMAL COIL WAS SEVERED FROM THE DISTAL END OF THE WIRE; SHARP EDGES WERE OBSERVED TO BE PRESENT. THE MICROCABLES WERE OBSERVED TO BE SEVERED AND PULLED FROM THE DISTAL END OF THE WIRE. IT CANNOT BE DETERMINED IF ALL PORTIONS OF THE DEVICE ARE PRESENT. SANGUINEOUS RESIDUE WAS PRESENT AT THE PROXIMAL COIL. THE WIRE WAS NOT RECOGNIZED DURING ZERO TESTING AND DRIFT TESTING COULD NOT BE CONDUCTED AS A RESULT. THE CUSTOMER STATED THAT REPORTED FAILURE OCCURRED "OUTSIDE THE BODY BEFORE FIRST USE, DURING PREP/LOADING." ADDITIONALLY IT WAS REPORTED THAT NO PHYSICAL DAMAGE TO THE DEVICE WAS OBSERVED AND NO PORTION OF THE DEVICE BECAME SEPARATED OR DETACHED. THE OBSERVED DAMAGE LIKELY OCCURRED SOMETIME AFTER THE DEVICE HAD FAILED BUT BEFORE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7526627 ↗
• MalfunctionApr 13, 2018Material Separation; Material Separation

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED DURING A PLANNED DIAGNOSTIC CORONARY PROCEDURE THE MANUFACTURER'S WIRE WAS RECOGNIZED BY THE SYSTEM, ZEROED AND NORMALIZED. PRIOR TO MEASUREMENT, THEY WERE UNABLE TO CROSS THE WIRE TO THE REQUIRED LOCATION. NO ERROR MESSAGE WAS DISPLAYED. NO TROUBLESHOOTING WAS PERFORMED. THE PROCEDURE WAS COMPLETED WITHOUT PRESSURE MEASUREMENT AS DIAGNOSTIC TOOL. NO PHYSICAL DAMAGE TO THE DEVICE WAS OBSERVED. NO RESISTANCE WAS ENCOUNTERED. THERE WAS NO STATUS DECLINE, EVIDENCE OF AN INJURY OR ANY REQUIRED INTERVENTION TO PREVENT INJURY. NO PORTION OF THE DEVICE BECAME SEPARATED OR DETACHED WITHIN THE PATIENT. NO EMBOLIZATION OCCURRED. VESSEL: UNKNOWN. OCCLUSION: UNKNOWN. ATTEMPTS TO GAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE SENSOR WAS BROKEN AND THE DIAPHRAGM OF THE SENSOR WAS MISSING. THE DISTAL COIL WAS KINKED AND CURVED. KINKS AND BENDS WERE OBSERVED ALONG THE HYPOTUBE. THE GUIDE WIRE WAS INSERTED INTO THE WIRE BEND TEST FIXTURE. THE TORQUE DEVICE WAS THEN TIGHTENED AND ROTATED IN ¼ TURN INCREMENTS COUNTERCLOCKWISE. ROTATION DID

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7428766 ↗
• MalfunctionMar 22, 2018Material Separation; Material Separation

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED DURING A CORONARY PROCEDURE WHERE THE MANUFACTURER'S DEVICE WAS USED FOR DIAGNOSTIC PURPOSES, AFTER CROSSING THE LESION INSIDE THE BODY, THE PD CURVE WAS UNSTABLE. THERE WAS NO PATIENT INJURY. VESSEL: LAD, OCCLUSION: 50%, TORTUOUSNESS: SLIGHTLY ADDITIONAL INFORMATION INDICATED NO DAMAGE WAS OBSERVED DURING PREP. AFTER NORMALIZATION AND DURING DELIVERING OF THE WIRE, THE USER FELT SOME RESISTANCE. AFTER REMOVAL FROM THE PATIENT THE USER NOTICED THE TIP WAS DAMAGED, APPEARING ALMOST SEPARATED. ALL PARTS OF THE DEVICE APPEARED TO BE PRESENT. THE PROCEDURE WAS ABORTED; NO OTHER PRODUCT WAS USED. THERE WERE NO ADVERSE EVENTS AND NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS PERFORMED. THE PATIENT WAS DISCHARGED AS EXPECTED IN "STABLE" CONDITION. VISUAL AND MICROSCOPIC INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED ON THE RETURNED DEVICE. THE WIRE CONNECTOR AND TORQUE DEVICE WERE NOT RETURNED FOR INVESTIGATION. THE DOME WAS CORRODED. THE DISTAL COIL WAS OBSERVED TO BE STRETCHED TO 60MM IN LENGTH BUT WAS INTACT. THE CORE WIRE WAS BROKEN AND THERE WAS TWISTING OF THE WIRE AT THE FRACTURE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7363051 ↗
• InjuryMar 22, 2018Crack; Crack

  IT WAS REPORTED THAT DURING A CORONARY PROCEDURE, AT THE FIRST INSERTION, AFTER THE WIRE WAS NORMALIZED INSIDE THE BODY AND THE PHASE OF PD AND PA MATCHED BUT THE SHAPE OF PD AND PA DIDN'T MATCH. AND THEN THE WIRE WAS DELIVERED TO DISTAL BUT SOME RESISTANCE WAS MET AND THE WIRE WAS REMOVED FROM THE BODY. AFTER REMOVAL OF THE WIRE, THE USER FOUND LIKE A THROMBUS OBJECTS WERE ATTACHED TO THE DISTAL PART OF THE SENSOR. THERE WAS NO PATIENT INJURY. THIS EVENT IS BEING REPORTED BECAUSE NEW INFORMATION OBTAINED ON 03-02-2018 INDICATED ADDITIONAL INTERVENTION VIA A BALLOON CATHETER WAS REQUIRED TO ASSIST REMOVAL OF THE MANUFACTURER'S DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7363024 ↗
• InjuryDec 28, 2017Material Distortion; Material Distortion

  IT WAS REPORTED THAT DURING A CORONARY PROCEDURE, WHEN CROSSING THE LESION INSIDE THE BODY SOME RESISTANCE WAS MET AND THE WIRE GOT STUCK IN A SMALL BRANCH. ANOTHER MANUFACTURERS WIRE WAS USED AND THE [MANUFACTURER'S] WIRE COULD REMOVE FROM THE BODY. THERE WAS NO PATIENT INJURY. PATIENT RELEASED AS EXPECTED IN STABLE CONDITION. VESSEL: RCA#3, ARTERY OCCLUSION: 50%, TORTUOUSNESS: SLIGHTLY. THIS EVENT IS BEING REPORTED BECAUSE ADDITIONAL INTERVENTION WAS PERFORMED IN AN ATTEMPT TO REMOVE THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7152201 ↗
• InjuryDec 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO UPDATE THE INITIAL REPORT WITH THE ANALYSIS FOR THE DEVICE RETURNED TO THE MANUFACTURER ASSOCIATED TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7144727 ↗
• MalfunctionAug 31, 2017Material Separation; Material Separation

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED DURING A CORONARY PROCEDURE, THE WIRE WAS ZEROED, POSITIONED AND RECONNECTED, AND THE SYSTEM DID NOT RECOGNIZE THE WIRE. THE WIRE WAS INTRODUCED INTO THE PATIENT. A SECOND WIRE OF SAME PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY. PATIENT WAS DISCHARGED AS EXPECTED. THERE IS NO KNOWN INDICATION A PIECE OR PORTION OF THE DEVICE WAS LEFT IN THE PATIENT. NO DAMAGE WAS OBSERVED DURING PREP. NO RESISTANCE WAS FELT AT ANY TIME. DEVICE WAS NOT STUCK IN A LESION OR OTHER DEVICE. ALL PORTIONS OF THE DEVICE APPEARED ACCOUNTED FOR AFTER REMOVAL FROM THE PATIENT. NO DAMAGE WAS OBSERVED AFTER REMOVAL. NO ADDITIONAL INTERVENTION WAS PERFORMED AND THERE WERE NO ADVERSE EVENTS. VISUAL AND MICROSCOPIC INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED ON THE RETURNED DEVICE. THE PRESSURE SENSOR WAS BROKEN AND THE DISTAL PORTION WAS MISSING FROM THE SENSOR. UNSTABLE, WEAK CONNECTIONS WERE OBSERVED DURING ELECTRICAL RESISTANCE TESTING. THE WIRE WAS NOT RECOGNIZED DURING ZERO TESTING. AS A RESULT, DRIFT TEST WAS NOT PERFORMED. THE PROBABLE CAUSE OF THE REPORTED FAILURE WAS AN ELECTR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6836574 ↗
• InjuryAug 25, 2017Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THE PHYSICIAN WIRED A SIDE BRANCH WITH THE MANUFACTURER'S GUIDEWIRE. THE WIRE GOT STUCK IN THE VESSEL, WHEREBY THE FIRST PHYSICIAN ASKED ASSISTANCE FROM ANOTHER PHYSICIAN TO RETRIEVE THE WIRE. WHEN THE SECOND PHYSICIAN TRIED TO RETRIEVE THE WIRE, THE SECOND PHYSICIAN SAW THE DISTAL SEGMENT WAS DISLODGED AND STICKING OUT IN THE AORTIC ROOT OF THE PATIENT. OPEN SURGERY WAS NEEDED TO REMOVE THE DISTAL PART OF THE WIRE FROM THE PATIENT. PATIENT IS HOME AND STARTING REHAB AFTER HER SURGERY AS STANDARD PROCEDURE. THIS EVENT IS BEING REPORTED BECAUSE SURGICAL INTERVENTION WAS REQUIRED TO REMOVE THE DEVICE.

  Patient problems: Foreign Body In Patient; Vascular Dissection

  MAUDE report 6822858 ↗
• MalfunctionJul 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. BY REPORT, PRIOR TO A DIAGNOSTIC CORONARY PROCEDURE, WHEN THE DEVICE WAS REMOVED FROM THE INNER STERILE PACKAGE, THE GUIDEWIRE WAS A J-TIP AND NOT A STRAIGHT TIP AS THE OUTER BOX LABEL INDICATED. THE PHYSICIAN OPTED TO USE THE J-TIP GUIDEWIRE FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT HARM AND THE PATIENT WAS DISCHARGED AS EXPECTED. VESSEL: MID LAD ROUGHLY 60% STENOSED, MINIMAL TORTUOSITY AND CALCIFICATION. THE DEVICE WAS DISCARDED POST-PROCEDURE AND NOT RETURNED FOR ANALYSIS. THE MANUFACTURER CONFIRMED THE SERIAL NUMBER REPORTED AS BEING ON THE OUTER PACKAGE IS FOR A STRAIGHT TIP GUIDEWIRE. AS THE DEVICE WAS DISCARDED, WE WERE UNABLE TO CONFIRM THE SERIAL NUMBER ON THE GUIDEWIRE WITHDRAWN FROM THE PACKAGE. THE FACILITY SAID THEY DID NOT NOTICE HOW THE GUIDEWIRE ITSELF WAS LABELED BEFORE IT WAS DISCARDED. THE MANUFACTURING DOCUMENTATION FOR THE REPORTED SERIAL NUMBER WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. THERE WERE NO NONCONFORMING MATERIAL REPORTS OR DEVIATIONS NOTED THAT WOULD CONTRIBUTE TO THE REPORTED FAILURE MODE. THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6712856 ↗
• InjuryJul 7, 2017Material Separation; Stretched; Material Separation; Stretched

  IT WAS REPORTED DURING A CORONARY PROCEDURE THE PHYSICIAN WIRED A SIDE BRANCH OF A PREVIOUSLY STENTED BIFURCATION WITH THE MANUFACTURER'S GUIDE WIRE. THE WIRE GOT STUCK IN THE VESSEL AND WHEN TRYING TO RETRACT IT, THE TIP OF THE WIRE WAS DAMAGED AND EXTENDED LIKE AN "ACCORDION." ADDITIONAL MANIPULATION USING A BALLOON AND ADDITIONAL WIRE WAS NEEDED TO GET THE DAMAGED WIRE OUT. THE PROCEDURE COULD BE COMPLETED WITHOUT ANY OBVIOUS COMPLICATIONS. THE PHYSICIAN DECIDED TO LET THE PATIENT STAY IN THE HOSPITAL FOR OBSERVATION. THE PATIENT IS DOING WELL. VESSEL: LAD; 60% CALCIFIED OSTIAL IN-STENT RESTENOSIS IN DIAGONAL BRANCH. ACUTE ANGLE AND MODERATE TORTUOUSNESS. THIS EVENT IS BEING REPORTED BECAUSE INTERVENTION WAS REQUIRED TO REMOVE THE DEVICE AND THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6695339 ↗