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

Model Number	40375
Medical Device Problem Codes	Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire entrapment occurred.A platinum plus guidewire was selected for use.It was difficult to advance the carotid wallstent delivery system over the guidewire to reach the target lesion.The stent was deployed in the target lesion without issue.Following deployment, the physician was unable to retract the stent delivery system from the guidewire.The stent delivery stent delivery system and guidewire were ultimately removed from the patient as a unit, and in one piece.The procedure was completed, and there were no patient complications as a result of this event.
Event or Problem Description
It was reported that guidewire entrapment occurred.A platinum plus guidewire was selected for use.It was difficult to advance the carotid wallstent delivery system over the guidewire to reach the target lesion.The stent was deployed in the target lesion without issue.Following deployment, the physician was unable to retract the stent delivery system from the guidewire.The stent delivery stent delivery system and guidewire were ultimately removed from the patient as a unit, and in one piece.The procedure was completed, and there were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device analysis: the platinum plus was returned for analysis.The device failed the visual and microscopic inspection, as the guidewire was stretched and kinked at the distal tip and distal transition section, confirming the reported event.

• 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: 22543416
• Report Number: 2124215-2025-45933
• Device Sequence Number: 7014005
• Product Code: DQX
• UDI-Device Identifier: 08714729486886
• UDI-Public: (01)08714729486886(17)280322(10)36130545
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 10/31/2025

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: 40375
• Device Catalogue Number: 40375
• Device Lot Number: 0036130545
• 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: 06/18/2025
• Supplement Date Received by Manufacturer: 10/05/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CAROTID WALLSTENT.; CAROTID WALLSTENT.
• Patient Sex: Unknown