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	06/25/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire coating peeled off.The target lesion was located in the liver.A 135 cm transend guidewire was selected for use.During preparation, the physician attempted to shape the distal tip 3-4 times and noted that the coating peeled off.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The unit returned has wire tip kinked, as part of overall visual revision.The device returned together with a torque device.The distal tip of the guidewire was found kinked.The guidewire body showed three kinked sections located approximately at 96.5 cm, 98 cm and 104 cm from the proximal end.The guidewire body did not show some damages on the coating, no peeled sections were found on the guidewire; the polymer tip was in good condition.No more damages were found in the device.The outer diameter of the distal tip, middle and proximal sections of the device are within specifications.
Event or Problem Description
It was reported that guidewire coating peeled off.The target lesion was located in the liver.A 135cm transend guidewire was selected for use.During preparation, the physician attempted to shape the distal tip 3-4 times and noted that the coating peeled off.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

• 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: 8776145
• Report Number: 2134265-2019-07988
• Device Sequence Number: 19290733
• 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): 09/13/2019

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: 08/09/2019
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1