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

Model Number	81735
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that coating issue occurred.The target lesion was located in superficial femoral artery.A 165cm transend periph guidewire was advanced for use.However, during procedure the physician noticed that the coating came off.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient's status was stable.
Event or Problem Description
It was reported that coating issue occurred.The target lesion was located in superficial femoral artery.A 165cm transend periph guidewire was advanced for use.However, during procedure the physician noticed that the coating came off.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: the returned device matches with upn provided by the customer.The guidewire returned with its original opened pouch along with an introducer guidewire and a torque device.The guidewire returned had the distal tip bent.The guidewire body was kinked approximately at 59.7 inches from the proximal end.No more visual damages were found in the returned device.The whole guidewire and the distal tip were carefully inspected and no abnormalities were found.The polymer jacket coating was in good condition; it was complete and no damages were observed.

• Brand Name: TRANSEND
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10416264
• Report Number: 2134265-2020-11152
• Device Sequence Number: 11359229
• Product Code: DQX
• UDI-Device Identifier: 08714729326281
• UDI-Public: 08714729326281
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K941710
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/19/2021
• Device Model Number: 81735
• Device Catalogue Number: 81735
• Device Lot Number: 0024804729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Initial Date Received by Manufacturer: 08/10/2020
• Supplement Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 09/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR