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

Model Number	39575
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Advance (2920); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that coating issue and guidewire entrapment occurred.The stenosed target lesion was located in the superficial femoral artery.A 035/260 amplatz super stiff guidewire was advanced across the lesion.A.035 non-boston scientific (bsc) stent was attempted to track over the wire; however, the stent would only track a short segment of the wire and got stuck.Multiple attempts were made at flushing the device and then pushing back over the wire without success.Both the wire and the stent were removed from the patient as one unit and the physician noticed an extra thick in a certain section of the wire as if the coating was bunched up on the wire.The procedure was completed with a non-bsc device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the complaint device was not returned by the customer; nevertheless, physician has provided pictures of the device.As per pictures provided, it can be observed four unopened amplatz pouches and a opened box.The information on the box and pouch labels matches with the information of the complaint.No damages were observed.
Event or Problem Description
It was reported that coating issue and guidewire entrapment occurred.The stenosed target lesion was located in the superficial femoral artery.A 035/260 amplatz super stiff guidewire was advanced across the lesion.A.035 non-boston scientific (bsc) stent was attempted to track over the wire; however, the stent would only track a short segment of the wire and got stuck.Multiple attempts were made at flushing the device and then pushing back over the wire without success.Both the wire and the stent were removed from the patient as one unit and the physician noticed an extra thick in a certain section of the wire as if the coating was bunched up on the wire.The procedure was completed with a non-bsc device.No patient complications were 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15065973
• Report Number: 2124215-2022-24384
• Device Sequence Number: 5976883
• Product Code: DQX
• UDI-Device Identifier: 08714729115830
• UDI-Public: 08714729115830
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K843015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2022

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: 04/20/2025
• Device Model Number: 39575
• Device Catalogue Number: 39575
• Device Lot Number: 0029267086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2022
• Supplement Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2022
• 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