MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMPLATZ SUPER STIFF; WIRE, GUIDE, CATHETER

Model Number	39575
Medical Device Problem Codes	Difficult to Advance (2920); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the guidewire was peeling off.This 035/145 amplatz super stiff guidewire was selected for use in a ureteral stent placement procedure to treat a 99% stenosed target lesion.During the procedure, when wiring was performed in the lesion, the wire did not advance easily.When it was removed from the body, the coating at the tip was noted to be peeling off.The procedure was completed with another of the same device.There were no patient complications reported.
Event or Problem Description
It was reported that the tip of the guidewire was peeling off.This 035/145 amplatz super stiff guidewire was selected for use in a ureteral stent placement procedure to treat a 99% stenosed target lesion.During the procedure, when wiring was performed in the lesion, the wire did not advance easily.When it was removed from the body, the coating at the tip was noted to be peeling off.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.The guidewire was returned, and it was observed that the coil wire was unraveled due the core wire was found detached separated from distal tip to the transition point.Also, the guidewire was stretched and bent at distal section.Based on the evidence, the as reported code guidewire difficult to advance can be confirmed, since the detached, stretched and bent found during the product inspection could have contributed to the reported issue.The as reported code body coating issue cannot be confirmed, since the reported code was not found during the product analysis.

• Brand Name: AMPLATZ SUPER STIFF
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20452422
• Report Number: 2124215-2024-63836
• Device Sequence Number: 7204181
• Product Code: DQX
• UDI-Device Identifier: 08714729295723
• UDI-Public: 08714729295723
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K843017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2024

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 Model Number: 39575
• Device Catalogue Number: 39575
• Device Lot Number: 0034159015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown