MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PLATINUM PLUS; WIRE, GUIDE, CATHETER

Model Number	40375
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that difficulty removal occurred.The target lesion was located in the lower ankle artery.A 014/300/sst platinum plus was selected for use.During advancing, the guidewire was kinked.The guidewire was pulled back, and it looked okay to continuing using it under fluoroscopy.Upon removal, it was noted that the guidewire could not be removed.Both the guidewire and the non-boston scientific balloon were removed.It was noted that the guidewire was damaged.The procedure was completed using an alternate device.No patient complications were reported.
Event or Problem Description
It was reported that difficulty removal occurred.The target lesion was located in the lower ankle artery.A 014/300/sst platinum plus was selected for use.During advancing, the guidewire was kinked.The guidewire was pulled back, and it looked okay to continuing using it under fluoroscopy.Upon removal, it was noted that the guidewire could not be removed.Both the guidewire and the non-boston scientific balloon were removed.It was noted that the guidewire was damaged.The procedure was completed using an alternate device.No patient complications were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this platinum plus guidewire was examined.The guidewire was returned inside an unknown catheter.It was observed that the guidewire was bent and stretched at the distal tip.No other issues were identified with the device and no patient complications were reported.

• Brand Name: PLATINUM PLUS
• 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; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19576760
• Report Number: 2124215-2024-35171
• Device Sequence Number: 3969893
• Product Code: DQX
• UDI-Device Identifier: 08714729486886
• UDI-Public: 08714729486886
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K945379
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

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 Expiration Date: 09/12/2026
• Device Model Number: 40375
• Device Catalogue Number: 40375
• Device Lot Number: 0032409462
• 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: 05/28/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2023
• 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