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	07/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guidewire fractured.The target lesion was 90% stenosed with normal tortuosity and very strong calcification.The target lesion was located in the fibular artery.A platinum plus pi guidewire and jet stream catheter were selected for use.During withdrawal of the platinum plus pi guidewire, the tip detached.The tip was retrieved by catheterization using a 0.018 guidewire.There were no further patient consequences.The procedure was completed.
Event or Problem Description
It was reported that the guidewire fractured.The target lesion was 90% stenosed with normal tortuosity and very strong calcification.The target lesion was located in the fibular artery.A platinum plus pi guidewire and jetstream catheter were selected for use.During withdrawal of the platinum plus pi guidewire, the tip detached.The tip was retrieved by catheterization using a 0.018 guidewire.There were no further patient consequences.The procedure was completed.
Additional Manufacturer Narrative
Device eval by mfr: the platinum plus guidewire was received for analysis.It was observed that the spring tip was detached from the guidewire and the core wire was detached near the distal tip section.The coil wire was also stretched.Under microscope it was confirmed that the core wire was detached near the distal tip section and the coil wire was stretched.The detachment section of the core wire was at approximately 0.6cm from the end of the distal braze solder.

• 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: 15210990
• Report Number: 2124215-2022-29670
• Device Sequence Number: 4601607
• Product Code: DQX
• UDI-Device Identifier: 08714729486886
• UDI-Public: 08714729486886
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2022

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: 05/18/2025
• Device Model Number: 40375
• Device Catalogue Number: 40375
• Device Lot Number: 0029427008
• 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: 08/04/2022
• Supplement Date Received by Manufacturer: 10/27/2022
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown