MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LUGE; WIRE, GUIDE, CATHETER

Model Number	2746
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/13/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guidewire tip detachment occurred.A 182cm luge guidewire was advanced to cross a lesion.However, it was noted that the distal tip of the wire got caught on the distal portion of the stent.The tip of the wire remained in the patient and another stent was placed against the wall to trap the wire so it would not move.No further patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the guidewire was returned with its original pouch; overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The visual inspection showed the distal tip of the device was kinked in different sections.A small section of the distal tip of the guidewire was detached; the damaged section was located approximately at 179.2 cm from the proximal end.The overall length and od of the distal tip could not be performed due to the device condition (distal end detached).The od of the middle of the device and the proximal section were within specification.No more damages were found in the inspected device.
Event or Problem Description
It was reported that guidewire tip detachment occurred.A 182cm luge guidewire was advanced to cross a lesion.However, it was noted that the distal tip of the wire got caught on the distal portion of the stent.The tip of the wire remained in the patient and another stent was placed against the wall to trap the wire so it would not move.No further patient complications were reported.
Event or Problem Description
It was reported that guidewire tip detachment occurred.A 182cm luge guidewire was advanced to cross a lesion.However, it was noted that the distal tip of the wire got caught on the distal portion of the stent.The tip of the wire remained in the patient and another stent was placed against the wall to trap the wire so it would not move.No further patient complications were reported.It was further reported that this issue was reported by the facility on a voluntary medwatch/maude report # 2700040000-2020-8020.After the guidewire was placed and pre-dilated the lesion with a balloon, a 3.0x24 synergy drug-eluting stent was implanted.However, the flow of the vessel was remained slow and so the guidewire was removed.During removal, a little resistance was encountered.A 2.75x20 stent was placed against the wall to trap the wire.No patient complications were reported and the patient was fine.
Additional Manufacturer Narrative
Updated b5: describe event or problem.Device evaluated by mfr.: the guidewire was returned with its original pouch; overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The visual inspection showed the distal tip of the device was kinked in different sections.A small section of the distal tip of the guidewire was detached; the damaged section was located approximately at 179.2 cm from the proximal end.The overall length and od of the distal tip could not be performed due to the device condition (distal end detached).The od of the middle of the device and the proximal section were within specification.No more damages were found in the inspected device.
Event or Problem Description
It was reported that guidewire tip detachment occurred.A 182cm luge guidewire was advanced to cross a lesion.However, it was noted that the distal tip of the wire got caught on the distal portion of the stent.The tip of the wire remained in the patient and another stent was placed against the wall to trap the wire so it would not move.No further patient complications were reported.It was further reported that this issue was reported by the facility on a voluntary medwatch / maude report#: (b)(4).After the guidewire was placed and pre-dilated the lesion with a balloon, a 3.0x24 synergy drug-eluting stent was implanted.However, the flow of the vessel was remained slow and so the guidewire was removed.During removal, a little resistance was encountered.A 2.75x20 stent was placed against the wall to trap the wire.No patient complications were reported and the patient was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: the guidewire was returned with its original pouch.Visual inspection showed the distal tip of the device was kinked in different sections.A small section of the distal tip of the guidewire was detached; the damaged section was located approximately at 70.55 inches from the proximal end.The overall length and od of the distal tip could not be performed due to the device condition (distal end detached).The od of the middle of the device and the proximal section were within specification.No more damages were found in the inspected device.Updated (h6) evaluation result codes.

• Brand Name: LUGE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9781431
• Report Number: 2134265-2020-02453
• Device Sequence Number: 504384
• Product Code: DQX
• UDI-Device Identifier: 08714729169956
• UDI-Public: 08714729169956
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K143587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/11/2021
• Device Model Number: 2746
• Device Catalogue Number: 2746
• Device Lot Number: 0024755555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2020
• Initial Date Received by Manufacturer: 02/14/2020
• Supplement Date Received by Manufacturer: 03/20/2020; 08/17/2020; 09/02/2020
• Initial Report FDA Received Date: 03/03/2020
• Supplement Report FDA Received Date: 03/24/2020; 08/31/2020; 09/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention