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

Model Number	39935
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that removal difficulties and device tip detachment occurred.Vascular access was gained via the pedal access approach.The target lesion was located in the popliteal artery.A.018 hydrophilic guidewire was selected to navigate up the extremely calcified tibial artery.The.018 hydrophilic guidewire was then exchanged for the platinum plus-3 018/260 guidewire to advance further into the patient.A crossing support catheter was used during the advancement of the platinum plus-3 018/260 guidewire as it would advance beyond the tibioperoneal trunk.As the platinum plus-3 018/260 guidewire was in the popliteal artery it started to back out of the support catheter.Force was applied and the guidewire was removed from the support catheter and from the patient.It was then noticed that 1cm of the guidewire tip was detached and remained in the vessel.Attempts were made to retrieve the detached tip; however, retrieval was unsuccessful.It was decided to leave the remaining piece inside the subintimal plane of the vessel.No patient complications were reported.
Additional Manufacturer Narrative
B3 date of event corrected from (b)(6) 2021 to (b)(6) 2021.
Event or Problem Description
It was reported that removal difficulties and device tip detachment occurred.Vascular access was gained via the pedal access approach.The target lesion was located in the popliteal artery.A.018 hydrophilic guidewire was selected to navigate up the extremely calcified tibial artery.The.018 hydrophilic guidewire was then exchanged for the platinum plus-3 018/260 guidewire to advance further into the patient.A crossing support catheter was used during the advancement of the platinum plus-3 018/260 guidewire as it would advance beyond the tibioperoneal trunk.As the platinum plus-3 018/260 guidewire was in the popliteal artery it started to back out of the support catheter.Force was applied and the guidewire was removed from the support catheter and from the patient.It was then noticed that 1cm of the guidewire tip was detached and remained in the vessel.Attempts were made to retrieve the detached tip; however, retrieval was unsuccessful.It was decided to leave the remaining piece inside the subintimal plane of the vessel.No patient complications were reported.It was further reported that the procedure was completed with other devices and simply ballooned the lesion.

• Brand Name: PLATINUM PLUS
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11323155
• Report Number: 2134265-2021-01558
• Device Sequence Number: 11764925
• Product Code: DQX
• UDI-Device Identifier: 08714729114574
• UDI-Public: 08714729114574
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2021

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: 01/07/2023
• Device Model Number: 39935
• Device Catalogue Number: 39935
• Device Lot Number: 0025006570
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 02/15/2021
• Initial Report FDA Received Date: 02/12/2021
• Supplement Report FDA Received Date: 02/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention