SUPER TORQUE 532598BRecalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 10705032012034), received between Mar 31, 2017 and Feb 16, 2026 — classified as 39 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (46 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 65 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 16, 2026Detachment of Device or Device Component

  AS REPORTED, WHILE USING THE 5FR 110CM SUPER TORQUE MARKING PIG CATHETER, TWO OF THE SIZING RINGS ON THE CATHETERS MOVED. ONE OF WHICH STAYED ON THE CATHETER THE OTHER COULD NOT BE LOCATED AFTER THE PROCEDURE. THE CATHETER SEPARATED AND BROKE OFF WITH PART REMAINING IN VESSEL. THE PIECE WAS REMOVED USING A SNARE; HOWEVER, THE RING WAS NOT REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING THE SAME CATHETER. THE PATIENT WAS REPORTED TO BE AMBULATORY THE FOLLOWING DAY. THE SIZING RING MOVED PRIOR TO THE MEASUREMENT. THE PROCEDURE PERFORMED WAS A VASCULAR INTERVENTION INVOLVING THE LEGS. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICE. NO ANOMALIES WERE OBSERVED WHEN THE DEVICE WAS TAKEN OUT OF THE PACKAGE, AND NO DIFFICULTIES WERE EXPERIENCED DURING PREPARATION. THERE WAS NO DAMAGE TO THE PACKAGING, AND THE PRODUCT WAS STORED IN A CABINET. NO ANOMALIES WERE NOTED UPON REMOVAL FROM THE PACKAGE. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU) WITHOUT DIFFICULTY. NO RESISTANCE OR FRICTION WAS ENCOUNTERED WHILE ADVANCING THE CATHETER THROUGH THE SHEATH, NO EXCESS FORCE WAS USED, AND THERE WAS NO DIFFICULTY TRACKING THROUGH THE VASCULATURE. THE DEVICE IS NOT BE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24344070 ↗
• MalfunctionJan 30, 2026Detachment of Device or Device Component

  AS REPORTED, A 5F 110CM SUPER TORQUE MARKER BAND PIGTAIL DIAGNOSTIC CATHETER RUPTURED IN THE PATIENT¿S ILIAC ARTERY DURING USE. THE FRAGMENT WAS RECOVERED DURING SURGERY. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU), THERE WAS NO DAMAGE TO THE DEVICE PRIOR TO USE, AND THERE WAS NO DIFFICULTY ADVANCING THE DEVICE WITHIN THE PATIENT PRIOR TO THE RUPTURE. ADDITIONAL DETAILS WERE REQUESTED BUT WERE UNKNOWN. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24222883 ↗
• MalfunctionNov 4, 2025Structural Problem; Structural Problem

  AS REPORTED, THE MARKER BAND OF A 5F PIG 110CM SUPER TORQUE MARKER BAND (MB) DIAGNOSTIC CATHETER WAS INSUFFICIENTLY BONDED TO THE CATHETER SHAFT AND SHOWED MOVEMENT. THE DEVICE WAS NOT USED FOR THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE PHYSICIAN ATTEMPTED TO USE THE CATHETER DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23463328 ↗
• MalfunctionSep 17, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  AS REPORTED, A 5F PIGTAIL (PIG) 110CM SUPER TORQUE MB DIAGNOSTIC CATHETER BECAME STUCK ON THE GUIDEWIRE DURING AN AORTOMONOILIAC ENDOGRAFT PROCEDURE AND DURING THE ATTEMPT TO REMOVE THE DEVICE, THE CATHETER BROKE, LEAVING APPROXIMATELY ONE-THIRD AT THE PATIENT¿S ACCESS SITE. THIS REQUIRED PARTIAL REMOVAL OF THE GUIDEWIRE AND CATHETER THROUGH THE INTRODUCER, FOLLOWED BY COMPLETE REMOVAL OF THE CATHETER, WHICH WAS DESCRIBED AS EXTREMELY DIFFICULT DUE TO TIGHT ADHESION TO THE GUIDEWIRE. THERE WAS A REPORTED PATIENT INJURY. THE DEVICE WAS USED FOR ANGIOGRAPHY AND SUBSEQUENT MEASUREMENT OF THE ENDOGRAFT LENGTH REQUIRED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS PERFORMED AS PART OF AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) COMPLETION IN A PATIENT WITH AN ABDOMINAL AORTIC ANEURYSM WITH A RIGHT TYPE IB ENDOLEAK AND A LEFT TYPE III ENDOLEAK, WITH A RAPIDLY ENLARGING ANEURYSM REACHING 10 CM IN DIAMETER. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23080555 ↗
• MalfunctionJul 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A GOLD MARKER ON A 5F 110CM 6 SIDE-HOLE (SH) SUPER TORQUE MARKER BAND (MB) DIAGNOSTIC CATHETER HAS COME OFF THE CATHETER. THERE WERE NO REPORTS OF PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22516491 ↗
• MalfunctionMay 14, 2025Degraded; Degraded

  AS REPORTED, THE PROXIMAL PART OF A 5F 110CM SUPER TORQUE MARKER BAND (MB) CATHETER BROKE OFF IN BLUE PIECES CLOSE TO THE HUB. THE DEVICE WAS NOT USED IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE CONDITION WAS NOTICED AFTER THE DEVICE WAS RECEIVED AND STORED IN THE LAB WHILE SHOWING A STUDENT THE DIFFERENCE IN SHAPES. THE DEVICE WAS STORED AND HANDLED AS PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICES ARE STORED IN THE LAB HANGING ON STORAGE HOOKS. THE ACCOUNT REQUESTED TO SEND BACK ALL CATHETERS WITH THAT LOT NUMBER (TOTAL OF 5 ADDITIONAL CATHETERS) ALTHOUGH NO ISSUES WERE NOTED IN THOSE. THE ACCOUNT WANTED TO PULL THOSE OFF THE SHELF. PICTURES WERE RECEIVED FOR REVIEW AND SHOW BLUE POLYMER FLAKES WITHIN THE PACKAGING THAT ORIGINATE FROM THE STRAIN RELIEF. THE DEVICES WERE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22020564 ↗
• MalfunctionMay 7, 2024Crack; Crack

  AS REPORTED, THE SURGEON HAD DIFFICULTY REMOVING A 5F 6 SIDE HOLES (SH) 110CM SUPER TORQUE MARKER BAND (MB) PIGTAIL CATHETER FROM AN UNKNOWN 6F SHEATH INTRODUCER DURING AN AORTIC GRAFT STENTING PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE DIFFICULTY REPORTED WAS DUE TO INTERACTION WITH THE SHEATH; SHEATH DETAILS ARE UNKNOWN. THE PROCEDURE WAS REPORTED AS AN AORTIC ENDOPROSTHESIS. LESION CALCIFICATION, VESSEL TORTUOSITY AND PERCENTAGE STENOSIS ARE UNKNOWN. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THE PRODUCT WAS STORED, HANDLED, INSPECTED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ONLY THE CATHETER IS AVAILABLE. ADDITIONAL EVENT DETAILS WERE REQUESTED; HOWEVER, COULD NOT BE OBTAINED. THE SUBMITTER FILED REPORT MAT-RV-2023-0439 WITH THE COMPETENT AUTHORITY. THE DEVICE WAS RETURNED FOR EVALUATION AND A CRACK CONDITION WAS OBSERVED ON THE BODY OF THE UNIT RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19261143 ↗
• MalfunctionApr 5, 2024Structural Problem; Structural Problem

  AS REPORTED, THE GOLD MARKER BANDS ON A 5F 110CM 6 SIDE-HOLE SUPER TORQUE 20 MARKER BAND (MB) DIAGNOSTIC CATHETER WERE VERY LOOSE ON THE SHAFT OF THE DEVICE. MARKER BAND MOVEMENT WAS OBSERVED PRIOR TO/DURING MEASUREMENT; HOWEVER, ALL MARKER BANDS REMAINED ON THE CATHETER. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. THE SUPER TORQUE MB CATHETER WAS NOT JAILED DURING THE PROCEDURE. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND ALL MARKER BANDS WERE PRESENT AND IN THEIR MANUFACTURED POSITION WHEN THE DEVICE WAS OPENED AND PREPPED. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19049795 ↗
• MalfunctionMar 28, 2024Structural Problem; Structural Problem

  AS REPORTED, THE GOLD MARKER BANDS ON A 5F 110CM 6 SIDE-HOLE SUPER TORQUE 20 MARKER BAND (MB) DIAGNOSTIC CATHETER WERE VERY LOOSE ON THE SHAFT OF THE DEVICE. MARKER BAND MOVEMENT WAS OBSERVED PRIOR TO/DURING MEASUREMENT; HOWEVER, ALL MARKER BANDS REMAINED ON THE CATHETER. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. THE SUPER TORQUE MB CATHETER WAS NOT JAILED DURING THE PROCEDURE. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND ALL MARKER BANDS WERE PRESENT AND IN THEIR MANUFACTURED POSITION WHEN THE DEVICE WAS OPENED AND PREPPED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18992794 ↗
• MalfunctionMar 27, 2024Structural Problem; Structural Problem

  ADDITIONAL EVENT DETAILS WERE REQUESTED; HOWEVER, NOT PROVIDED. THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18987975 ↗
• InjuryDec 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18297554 ↗
• InjuryDec 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18297517 ↗
• MalfunctionOct 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE MARKER RINGS SLID OUT OF THE PACKAGING OF THE 5F 110CM 6 SIDE HOLES (SH) SUPER TORQUE PIGTAIL MARKER BAND (MB) ANGIOGRAPHIC CATHETER. THE MARKER BANDS WERE STILL ON THE CATHETER, THEY ONLY "REMOVE" THE POSITION. THE CATHETER WAS NOT INSERTED IN THE PATIENT AFTERWARDS. ANOTHER SUPER TORQUE WAS USED TO COMPLETE THE PROCEDURE. PROCEDURAL DETAILS WERE NOT PROVIDED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO VISIBLE SIGNS OF DEVICE/PACKAGING DAMAGE PRIOR TO USE OR ANOMALIES NOTED WHEN THE DEVICE WAS TAKEN OUT OF THE PACKAGE NOR EXCESSIVE FORCE APPLIED TO THE DEVICE DURING WITHDRAWAL FROM THE PACKAGE. THE EVENT DID NOT CAUSE A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE PROCEDURE NOR CAUSED A CONDITION THAT REQUIRED HOSPITALIZATION OR SIGNIFICANT PROLONGATION OF EXISTING HOSPITALIZATION. TWO DEVICE PICTURES WERE PROVIDED FOR REVIEW. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17929896 ↗
• InjuryJul 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE DISTAL PART OF A 5F SUPER TORQUE MARKER BAND (MB) CATHETER SEPARATED UPON REMOVAL, LEAVING 20CM OF THE DEVICE IN THE PATIENT¿S ABDOMINAL THORACIC AORTA. THE BROKEN DEVICE WAS RECOVERED WITH A LASSO A ¿RANCH ROPE¿. THE PATIENT RECOVERED. THE DEVICE WAS BEING USED IN AN ENDOVASCULAR ANEURYSM REPAIR (EVAR). THE TARGET LESION WAS A AAA ABDOMINAL AORTIC ANEURYSM. VESSEL/LESION CALCIFICATION, TORTUOSITY AND STENOSIS ARE UNKNOWN. THE DEVICE WAS NOT BEING USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THERE WERE NO ANOMALIES NOTED WHEN THE PRODUCT WAS REMOVED FROM THE PACKAGE. THE PRODUCT WAS STORED, HANDLED, INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THE DEVICE WAS NOT INSERTED THROUGH A STOPCOCK. THERE WAS RESISTANCE/FRICTION EXPERIENCED DURING PART OF THE PROCEDURE. UNUSUAL FORCE WAS NECESSARY TO RETRIEVE THE DEVICE. IT IS NOT KNOWN IF THE TIP WAS VISIBLE ON FLUOROSCOPY THROUGHOUT THE PROCEDURE. IT IS ALSO UNKNOWN IF THERE WAS DIFFICULTY EXPERIENCED WHEN REMOVING THE PRODUCT FROM THE PATIENT. THE PATIENT WAS NOT HOSPITALIZED OR REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THIS EVENT. A PROCED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17325028 ↗
• InjuryDec 22, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A 5F 110CM 6SH PIGTAIL SUPER TORQUE ANGIOGRAPHIC CATHETER RUPTURED INTRAVASCULARLY WHEN IT WAS PULLED OUT DURING AN ANGIOGRAPHIC PROCEDURE. AS A RESULT, ONLY THE LOWER PART OF THE CATHETER WAS WITHDRAWN INITIALLY, AND THE TIP REMAINED IN THE PATIENT'S VESSEL, UNTIL IT WAS SUBSEQUENTLY RETRIEVED VIA A SNARE. THERE WERE NO REPORTS OF PATIENT INJURY. THE INCIDENT HAPPENED WHILE USING A NON-CORDIS PROSTHESIS. THERE WERE PROBLEMS WITHDRAWING THE CATHETER FROM THE PATIENT AND THE CATHETER RUPTURED. 2 GOLD MARKERS HAD REMAINED IN THE PATIENT: ONE IN THE PROSTHESIS AND THE OTHER SLIPPED IN THE LEG. THE PATIENT IS DOING WELL SO FAR. THE ACCESS VESSEL SITE WAS THE FEMORAL ARTERY. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THE USER OF THE DEVICE WAS TRAINED. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 16040706 ↗
• InjuryDec 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A 5F PIGTAIL 110CM 6SH (SIDEHOLES) SUPER TORQUE CATHETER SEPARATED MOST PROBABLY UP TO THE LAST MARKER SPOT AND ALL THE MARKERS HAVE BROKEN OFF WHEN REMOVING AFTER USING AN UNKNOWN HIGH-PRESSURE MACHINE AT FIRST RUN. WHEN THE BROKEN PIGTAIL TIP WAS LOOKED AT THE MARKERS HAVE ALSO MIGRATED, AND DID NOT DISLODGE BUT IT WAS UNSURE IF THIS WAS AT THE TIME WHEN THEY WERE TRYING TO NON-CORDIS SNARE THE TIP OUT OR BEFORE EVERYTHING HAPPENED. ANOTHER UNKNOWN CATHETER WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT INJURY. THE DEVICE WAS STORED, HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE. THE INTENDED PROCEDURE WAS AN ENDOVASCULAR ANEURYSM REPAIR (EVAR). THE DEVICE WAS NOT INSERTED THROUGH A STOPCOCK INSTEAD OF A HEMOSTATIC VALVE. THERE WAS NO RESISTANCE MET WHILE ADVANCING THE DEVICE. THE LESION WAS NOT CALCIFIED NOR WAS THERE VESSEL TORTUOSITY OR VESSEL ANGULATION. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THERE WAS NO EXCESSIVE TORQUEING REQUIRED. THE DEVICE WAS NOT KINKED IN THE AREA OF SEPARATION. THE D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16000419 ↗
• MalfunctionDec 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE RINGS OF A 5F PIGTAIL SUPERTORQUE MARKER BAND (MB) WITH 6 SIDE HOLES (SH) GUIDING CATHETER MOVED AND STARTED TO STACK UP ON THE CATHETER. ANOTHER 5F PIGTAIL SUPERTORQUE MARKER BAND (MB) WITH 6 SIDE HOLES (SH) GUIDING CATHETER WAS USED AND IT BROKE/SEPARATED INTO TWO PIECES IN AN UNKNOWN SHEATH. THE SEPARATED PART OF THE CATHETER REMAINED WITHIN THE SHEATH AND NO SECONDARY INTERVENTION WAS REQUIRED TO RETRIEVE THE SEPARATED PART OF THE CATHETER. THE PROCEDURE WAS COMPLETED BY USING A THIRD UNKNOWN CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED, HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE INTENDED PROCEDURE WAS AORTIC STENTING. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15974169 ↗
• InjuryJul 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE MARKER OF A 5F 110CM 6 SIDE HOLE (SH) PIGTAIL SUPER TORQUE CATHETER FELL OFF DURING THE SURGICAL PROCESS AND SOME OF IT IS STILL IN THE PATIENT ABDOMEN. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 14955864 ↗
• MalfunctionJun 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A 5F PIG 110CM 6SH SUPER TORQUE® MARKER BAND PIGTAIL CATHETER BROKE INTO 2 PIECES DURING AN AORTA TYPE B DISSECTION TREATMENT PROCEDURE. CATHETER WAS REMOVED AND THE PROCEDURE WAS FINISHED SUCCESSFULLY. THERE WERE NO REPORTS OF PATIENT INJURY. THE WIRE POSITION HAD TO BE GIVEN UP TO SALVAGE THE CATHETER. THE PRODUCT WAS DISCARDED AND THEREFORE WILL NOT BE RETURNED FOR EVALUATION. ACCORDING TO ADDITIONAL DETAILS PROVIDED, THE DEVICE WAS NOT BEING USED FOR A CHRONIC TOTAL OCCLUSION. THERE WERE NO ANOMALIES NOTED WHEN THE PRODUCT WAS REMOVED FROM THE PACKAGE. THE PRODUCT WAS STORED, HANDLED, INSPECTED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THE DEVICE WAS NOT INSERTED THROUGH A STOPCOCK. THE DEVICE WAS NOT RESTERILIZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14804711 ↗
• InjuryJun 13, 2022Adverse Event Without Identified Device or Use Problem

  AS REPORTED, A DOCTOR CALLED THE DISTRIBUTOR INFORMING THAT THE 5F 6 SIDE HOLES (SH)110CM SUPER TORQUE MARKER BAND (MB) PIGTAIL CATHETER (CATH MB 5F PIG 110CM 6SH) RESECTED THE AORTA DURING THE USE. THIS ISSUE HAPPENED TWO TIMES IN LESS THAN 24 HOURS (TWO DIFFERENT PATIENTS WITH TWO DIFFERENT PRODUCTS). NO OTHER INFORMATION COULD BE OBTAINED. ADDITIONAL EVENT DETAILS WERE NOT PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 14682228 ↗
• InjuryJun 13, 2022Adverse Event Without Identified Device or Use Problem

  AS REPORTED, A DOCTOR CALLED THE DISTRIBUTOR INFORMING THAT THE 5F 6 SIDE HOLES (SH)110CM SUPER TORQUE MARKER BAND (MB) PIGTAIL CATHETER (CATH MB 5F PIG 110CM 6SH) RESECTED THE AORTA DURING THE USE. THIS ISSUE HAPPENED TWO TIMES IN LESS THAN 24 HOURS (TWO DIFFERENT PATIENTS WITH TWO DIFFERENT PRODUCTS). NO OTHER INFORMATION COULD BE OBTAINED. ADDITIONAL EVENT DETAILS WERE NOT PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 14682092 ↗
• InjuryJun 13, 2022Adverse Event Without Identified Device or Use Problem

  AS REPORTED, A DOCTOR CALLED THE DISTRIBUTOR INFORMING THAT THE 5F 6 SIDE HOLES (SH)110CM SUPER TORQUE MARKER BAND (MB) PIGTAIL CATHETER (CATH MB 5F PIG 110CM 6SH) RESECTED THE AORTA DURING THE USE. THIS ISSUE HAPPENED TWO TIMES IN LESS THAN 24 HOURS (TWO DIFFERENT PATIENTS WITH TWO DIFFERENT PRODUCTS). NO OTHER INFORMATION COULD BE OBTAINED. ADDITIONAL EVENT DETAILS WERE NOT PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 14681529 ↗
• InjuryJun 13, 2022Adverse Event Without Identified Device or Use Problem

  AS REPORTED, A DOCTOR CALLED THE DISTRIBUTOR INFORMING THAT THE 5F 6 SIDE HOLES (SH)110CM SUPER TORQUE MARKER BAND (MB) PIGTAIL CATHETER (CATH MB 5F PIG 110CM 6SH) RESECTED THE AORTA DURING THE USE. THIS ISSUE HAPPENED TWO TIMES IN LESS THAN 24 HOURS (TWO DIFFERENT PATIENTS WITH TWO DIFFERENT PRODUCTS). NO OTHER INFORMATION COULD BE OBTAINED. ADDITIONAL EVENT DETAILS WERE NOT PROVIDED. NO OTHER INFORMATION COULD BE OBTAINED. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, INCLUDING, BUT NOT LIMITED TO PATIENT INFORMATION, CLARIFICATION ON THE NUMBER OF PATIENTS AND LOT NUMBER WAS REQUESTED; HOWEVER, ADDITIONAL INFORMATION COULD NOT BE OBTAINED.

  Patient problems: Vascular Dissection

  MAUDE report 14681212 ↗
• InjuryMay 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE PROBE OF A 5F 110CM 6 SIDE HOLES (SH) SUPER TORQUE PIGTAIL MARKER BAND (MB) ANGIOGRAPHIC CATHETER WAS TORN, AND THE RADIOLABELED RINGS BECAME LOOSE BUT NOT INSIDE THE PATIENT. THE DEVICE WAS USED IN THE IDENTIFICATION PHASE OF THE LEFT ILIAC LEG DURING ENDOPROSTHESIS FOR AN ANEURYSM OF THE ABDOMINAL AORTA. THE PROBE THEREFORE HAD TO BE WITHDRAWN THROUGH THE SKIN AFTER REMOVAL OF THE SHEATH INTRODUCER AND VERY LIKELY DAMAGED THE PERCUTANEOUS CLOSURE SYSTEM. AT THE END OF THE PROCEDURE, THERE WAS FAILURE OF THE PERCUTANEOUS CLOSURE AND OCCURRENCE OF HEMORRHAGE, FOR WHICH PROLONGED MANUAL COMPRESSION WAS REQUIRED, "AGGRESSIVE" PRESSURE DRESSING WITH ¿SCARPA ¿AND ARMED SURVEILLANCE IN INTENSIVE CARE IN ADDITION TO ECHO CONTROL DOPPLER AT D+1 WITHOUT PARTICULARITY. NOTE THAT THE PRACTITIONER IS AWARE OF SAFETY INFORMATION R2123558, THE DEVICE WAS ONLY USED IN THE IDENTIFICATION PHASE OF THE LEFT ILIAC LEG (NOT A PRIORITY RISK OF THE CATHETER BEING STUCK BETWEEN THE ENDOVASCULAR DEVICES AND THE VASCULAR WALL AS MENTIONED IN THE ALERT). THE DEVICE WAS BEING USED FOR AN ABDOMINAL AORTA ANEURYSM AND A LEFT ILIAC APPROACH WAS USED. VESSEL CALCIFICATION, TORTUOSITY AND STENOS

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14452969 ↗
• InjuryMay 10, 2022Fracture; Separation Failure; Fracture; Separation Failure

  WHILE REMOVING A 5F PIG 110CM 6SH SUPERTORQUE CATHETER WITH MARKER BANDS FROM A 6F CORDIS SHEATH CATHETER, THE DOCTOR NOTICED SMALL FRICTION BUT NOTHING CONCERNING. HE DID NOT USE EXCESSIVE FORCE TO PULL OUT THE CATHETER BUT WHEN THE CATHETER WAS OUT OF THE SHEATH, THE PHYSICIAN NOTICED THAT THE DISTAL PORTION (OF THE MB) WAS MISSING, APPROXIMATELY 20CM FROM THE DISTAL END. THE XRAY INDICTED THAT THE DISTAL PART REMAINED OVER THE WIRE IN THE BIFURCATION PROXIMALLY TO DISTALLY IN THE LEFT COMMON FEMORAL ARTERY(CFA). OPEN LEFT CFA EXPLORATION WAS PREFORMED AND CFA ARTHROTOMY WAS PREFORMED TO REMOVE THE CATHETER. THE PATIENT IS DOING WELL AND WAS DISCHARGED. THERE WAS NO CALCIFICATION, VESSEL TORTUOSITY OR STENOSIS PRESENT. THE DEVICE WAS NOT RESTERILIZED. THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE AND NO ANOMALIES NOTED DURING PRE. THE DEVICE WAS NOT INSERTED THROUGH A STOPCOCK INSTEAD OF A HEMOSTATIC VALVE. A PERIPHERAL ANGIOGRAPHY TRANSFEMORAL RIGHT TO LEFT WAS PERFORMED. THE WIRE WAS INSERTED TO A 6F CORDIS SHEATH FROM THE RIGHT FEMORAL , THE CATHETER WAS INSERTED OVER THE WIRE TO PASS THE BIFURCATION THE CATHETER WAS PLACED WITH ITS TIP IN THE LEFT CFA, A WIRE EX

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14345696 ↗