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

Model Number	40295
Medical Device Problem Codes	Difficult to Remove (1528); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that the guidewire was difficult to remove.The stenosed target lesion was located in the moderately tortuous and severely calcified vessel.A.018/260 cm platinum plus guidewire was selected for use during the procedure.While operating within a heavily occluded vessel, the surgeon attempted to withdraw the guidewire.During this process, the wire uncoiled inside the patient.Notably, there was no harm to the patient, and the guidewire remained intact despite the uncoiling.The device was removed by pulling even after it uncoiled.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).The device was returned for analysis packaged in a generic plastic bag.Initial visual inspection did not reveal any obvious failures or findings that could be compromised by the decontamination process.Upon further inspection, it was observed that the proximal braze attachment had become detached.
Event or Problem Description
It was reported that the guidewire was difficult to remove.The stenosed target lesion was located in the moderately tortuous and severely calcified vessel.A.018/260 cm platinum plus guidewire was selected for use during the procedure.While operating within a heavily occluded vessel, the surgeon attempted to withdraw the guidewire.During this process, the wire uncoiled inside the patient.Notably, there was no harm to the patient, and the guidewire remained intact despite the uncoiling.The device was removed by pulling even after it uncoiled.There were no patient complications as a result of this 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: 21890868
• Report Number: 2124215-2025-25484
• Device Sequence Number: 12798568
• Product Code: DQX
• UDI-Device Identifier: 08714729326212
• UDI-Public: (01)08714729326212(17)260917(10)32446838
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2025

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 Expiration Date: 09/17/2026
• Device Model Number: 40295
• Device Catalogue Number: 40295
• Device Lot Number: 0032446838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2023
• 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