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

Model Number	39895
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tip detached and remained in the patient.A 018/260 platinum plus guidewire was selected for use in a calcified recanalization procedure, within the superficial femoral artery (sfa).The lesion was severely calcified and 90% stenosed, with moderate tortuosity.During the procedure, using a non-boston scientific support catheter, the tip of the platinum plus guidewire hooked behind a calcified plaque and broke off the core of the wire.The piece of the tip was impacted into the vessel wall, with a stent and no further consequences occurred to the patient.The procedure was completed with a non-bsc support catheter.
Event or Problem Description
It was reported that the tip detached and remained in the patient.A 018/260 platinum plus guidewire was selected for use in a calcified recanalization procedure, within the superficial femoral artery (sfa).The lesion was severely calcified and 90% stenosed, with moderate tortuosity.During the procedure, using a non-boston scientific support catheter, the tip of the platinum plus guidewire hooked behind a calcified plaque and broke off the core of the wire.The piece of the tip was impacted into the vessel wall, with a stent and no further consequences occurred to the patient.The procedure was completed with a non-bsc support catheter.
Additional Manufacturer Narrative
Device eval by manufacturer: the guidewire was returned, and it was observed that the distal section of the core wire was detached, and the coil wire was unraveled.The overall length specification did not pass, due to the detached condition of the guidewire.The reported distal tip "detachment of device or device component" event was confirmed.

• Brand Name: PLATINUM PLUS
• 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; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15962158
• Report Number: 2124215-2022-52064
• Device Sequence Number: 14869980
• Product Code: DQX
• UDI-Device Identifier: 08714729035961
• UDI-Public: 08714729035961
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K935997
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/21/2025
• Device Model Number: 39895
• Device Catalogue Number: 39895
• Device Lot Number: 0029086863
• 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: 12/07/2022
• Supplement Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown