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

Model Number	39575
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire coating issue occurred.A 035/180 amplatz super stiff guidewire was selected for use.However, during removal, it was noted that the outer coating part of the wire sheared off.The device was completely retrieved without difficulty and the procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: unit returned with its original pouch batch.The unit returned has part of the tip detached, as part of overall visual revision.The returned device matches with upn provided by the customer.The returned guidewire had the distal end section kinked, stretched and unraveled.Also the wire and coil distal tip was detached and unraveled.No more visual damages were found in the device.Detailed pictures of the stretched area and the core wire were captured.It was observed that the core wire was detached from the distal end solder ball and wire broken.Dimensional inspection was performed where the overall diameter (od) was measured.The overall length and distal tip od shows the gudiewire was stretched.The middle and proximal section od are within specification.
Event or Problem Description
It was reported that guidewire coating issue occurred.A 035/180 amplatz super stiff guidewire was selected for use.However, during removal, it was noted that the outer coating part of the wire sheared off.The device was completely retrieved without difficulty and the procedure was completed with another of the same device.There were no patient complications reported.

• Brand Name: AMPLATZ SUPER STIFF
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11695322
• Report Number: 2134265-2021-04551
• Device Sequence Number: 3495196
• Product Code: DQX
• UDI-Device Identifier: 08714729295730
• UDI-Public: 08714729295730
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K843013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2021

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: 01/21/2024
• Device Model Number: 39575
• Device Catalogue Number: 39575
• Device Lot Number: 0026672784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 05/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1