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	07/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that coating issue were encountered.The target lesion was located in the liver.A 135cm transend guidewire was selected for use.However, during procedure outside the patient, when physician attempted to shape the distal tip 3-4 times, it was noticed that the coating of the distal tip 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 device returned together with a torque device attached.The device was inspected looking for the coating issues reported by the customer and the surface looked in good condition with some possible blood residues on its surface.Post decontamination, the surface of the device was visually inspected again.The distal tip of the guidewire was found kinked, however, no peeled sections were found.The guidewire body showed some peeled sections; they were located on the proximal end where the torque device is commonly used.Besides, some blood residues were found on the guidewire surface.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.No more damages were found in the device.The overall length, outer diameter of the distal tip, middle of the device and proximal secrion were within specifications.
Event or Problem Description
It was reported that coating issue were encountered.The target lesion was located in the liver.A 135cm transcend guidewire was selected for use.However, during procedure outside the patient, when physician attempted to shape the distal tip 3-4 times, it was noticed that the coating of the distal tip 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: 8837150
• Report Number: 2134265-2019-08822
• Device Sequence Number: 2743145
• 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): 09/24/2019

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: 02/28/2021
• Device Model Number: 81735
• Device Catalogue Number: 81735
• Device Lot Number: 0023423294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 07/29/2019
• Supplement Report FDA Received Date: 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1