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	07/14/2019
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 analysis of returned product revealed the coating damage found in the proximal end of the device was possibly caused by the torque device, due to the damage was located in the section of guidewire where the torque is commonly used (proximal end); the rest of the guidewire did not show damages on its coating, consequently, it is not possible to confirm the reported complaint.Besides, it is important to mention that the torque device returned exactly located where the guidewire was kinked and the coating damaged and residues of coating were encountered in the metallic collet of the torque device as well as inside the white cap.
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.

• 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: 8822625
• Report Number: 2134265-2019-08649
• Device Sequence Number: 19542638
• 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: 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: 08/09/2019
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 07/24/2019
• 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