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

Model Number	40375
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred.Vascular access was obtained via up-and-over technique.The 100% stenosed target lesion was located in the non-tortuous and moderately calcified superficial femoral artery.A 014/300/sst platinum plus guidewire and a non-boston scientific (bsc) support catheter were advanced into the lesion.However, during the procedure, the guidewire tip fractured.The detached fragment was retrieved by snaring and arterial exploration.The procedure was completed with another of same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: unit returned in a generic plastic bag.The unit returned has tip damaged, as part of overall visual revision.The wire returned was inspected and it is possible to observe the spring tip is unraveled and detached and corewire bent and detached.The outer dimensions were found within specification.The device was sent for material analysis, and evidence of necking, cone fracture surface and irregular appearance on the top of the coil suggest that it experienced a tensile load.The curved mechanical marks also suggest that it experienced twisting or bending actions.
Event or Problem Description
It was reported that tip detachment occurred.Vascular access was obtained via up-and-over technique.The 100% stenosed target lesion was located in the non-tortuous and moderately calcified superficial femoral artery.A 014/300/sst platinum plus guidewire and a non-boston scientific (bsc) support catheter were advanced into the lesion.However, during the procedure, the guidewire tip fractured.The detached fragment was retrieved by snaring and arterial exploration.The procedure was completed with another of same device.No patient complications were reported.

• 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: 15188065
• Report Number: 2124215-2022-26174
• Device Sequence Number: 17618640
• Product Code: DQX
• UDI-Device Identifier: 08714729486886
• UDI-Public: 08714729486886
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/27/2022

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: 05/01/2025
• Device Model Number: 40375
• Device Catalogue Number: 40375
• Device Lot Number: 0029321270
• 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: 07/12/2022
• Supplement Date Received by Manufacturer: 09/04/2022
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SUPPORT CATHETER: TRAILBLAZER; SUPPORT CATHETER: TRAILBLAZER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Race: Black Or African American