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	04/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a coating issue occurred.The target lesion was located in the prostatic artery.A 165cm transend guide wire was selected for use for a prostatic artery embolization procedure.When the wire was being removed from the catheter, it was ran through a moist 4x4 to wipe it clean after it was entered into the patient's body.It was then noticed that the coating on the wire was coming off.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned in a generic plastic bag.It was found that the device was severely kinked at the distal section.On the other hand, the coating of the device was inspected under high magnification and no failures were found.Outer diameter of distal tip, middle of the device and proximal section are within specifications.The device was measured according to the drawings.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that a coating issue occurred.The target lesion was located in the prostatic artery.A 165cm transend guide wire was selected for use for a prostatic artery embolization procedure.When the wire was being removed from the catheter, it was ran through a moist 4x4 to wipe it clean after it was entered into the patient's body.It was then noticed that the coating on the wire was coming off.The procedure was completed with another of the same device.No patient complications were reported.

• 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: 8607971
• Report Number: 2134265-2019-05113
• Device Sequence Number: 2180039
• Product Code: DQX
• UDI-Device Identifier: 08714729326281
• UDI-Public: 08714729326281
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K941710
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2019

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: 01/20/2021
• Device Model Number: 81735
• Device Catalogue Number: 81735
• Device Lot Number: 0023222495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Initial Date Received by Manufacturer: 04/26/2019
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 06/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1