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

Model Number	39615
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, visual inspection of the returned guidewire found that it was bent and stretched at the distal tip section.Based on the evidence, the reported clinical observation was confirmed due to the device condition.
Event or Problem Description
It was reported that device entrapment occurred.A 035/180/3mm (b/1) amplatz super stiff guidewire was selected for treatment on the patient's target lesion located in the pacemaker.During the procedure, the device got stuck and was replaced for another of the same model to complete the procedure.No patient complications were reported.It was further reported that the amplatz guidewire was difficult to advance into the lesion with a non-boston scientific (bsc) sheath that was estimated to be 5fr.This occurred in a case where a non-bsc leadless pacemaker was placed, when approaching from the groin.Additionally, although there was some difficulty, the amplatz device was removed normally.
Event or Problem Description
It was reported that device entrapment occurred.A 035/180/3mm (b/1) amplatz super stiff guidewire was selected for use during a leadless pacemaker implant.During the procedure, the device got stuck and was replaced for another of the same model to complete the procedure.No patient complications were reported.

• 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: 19344517
• Report Number: 2124215-2024-28099
• Device Sequence Number: 8693012
• Product Code: DQX
• UDI-Device Identifier: 08714729295648
• UDI-Public: 08714729295648
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K843012
• 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): 07/01/2024

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: 39615
• Device Catalogue Number: 39615
• Device Lot Number: 0033446990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2024
• 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