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

Model Number	81735
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 70 years old.
Event or Problem Description
It was reported that coating was peeled off.During a transarterial chemoembolization, a 135cm transend guide wire was selected for use.However, after one use, it was noted that the coating was peeled easily.The procedure was completed with a different device.No patient complications were reported and patient's status was good.
Event or Problem Description
It was reported that coating was peeled off.During a transarterial chemoembolization, a 135cm transend guide wire was selected for use.However, after one use, it was noted that the coating was peeled easily.The procedure was completed with a different device.No patient complications were reported and patient's status was good.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The device returned together with a torque device attached.The distal tip of the guidewire was found kinked.The guidewire body showed a kinked section located approximately at 13 cm from the proximal end.The guidewire body showed some peeled sections; all of them were located in the proximal end where the torque device is commonly used.The torque device was inspected and no damages were found; however, it was disassembled and it showed inside some residues (debris) of the guidewire coating.Most of them were located in the metallic collet and the interior of the white cap.The outer diameter of the distal tip, middle and proximal sections of the device are within specifications.The overall length dimension was within specification.

• 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: 8851301
• Report Number: 2134265-2019-09090
• Device Sequence Number: 10845050
• Product Code: DQX
• UDI-Device Identifier: 08714729326274
• UDI-Public: 08714729326274
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2019

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: 01/23/2021
• Device Model Number: 81735
• Device Catalogue Number: 81735
• Device Lot Number: 0023239935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Initial Date Received by Manufacturer: 07/22/2019
• Supplement Date Received by Manufacturer: 09/03/2019
• Initial Report FDA Received Date: 08/01/2019
• Supplement Report FDA Received Date: 09/11/2019
• 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