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

Model Number	40375
Medical Device Problem Codes	Unraveled Material (1664); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the guidewire unraveled and the distal tip detached.A 014/300/sst platinum plus guidewire was advanced in the non-tortuous, mildly calcified, peroneal artery, for treatment of peripheral artery disease.Once the guidewire reached the artery the physician noticed the guidewire was elongating and the distal tip was not moving.It was identified that the guidewire unraveled and the distal tip detached.A thruway guidewire was used to help advance the platinum guidewire, by wrapping it around the distal aspect of the wire.Then in the peroneal artery, a non-boston scientific device was used to retrieve the distal tip of the platinum plus guidewire.The devices were removed as a unit from the patient, with no patient complications.The case was successfully completed with a thruway 0.014 300cm.
Additional Manufacturer Narrative
Device eval.By manufacturer: upon receipt at our post market quality assurance laboratory, this platinum plus guidewire was examined.The guidewire was returned with a non-boston scientific device.Visual examination revealed the spring tip was unraveled and stretched.The device was sent for material analysis by scanning electron microscopy inspection.The device presented evidence of material folding and mechanical marks at the distal end of the wire.This indicates that the wire experienced tension/compression, caused by reverse bending action, resulting in the final fracture.The corewire was also bent and detached.The reported clinical observations were confirmed.
Event or Problem Description
It was reported that the guidewire unraveled and the distal tip detached.A 014/300/sst platinum plus guidewire was advanced in the non-tortuous, mildly calcified, peroneal artery, for treatment of peripheral artery disease.Once the guidewire reached the artery the physician noticed the guidewire was elongating and the distal tip was not moving.It was identified that the guidewire unraveled and the distal tip detached.A thruway guidewire was used to help advance the platinum guidewire, by wrapping it around the distal aspect of the wire.Then in the peroneal artery, a non-boston scientific device was used to retrieve the distal tip of the platinum plus guidewire.The devices were removed as a unit from the patient, with no patient complications.The case was successfully completed with a thruway 0.014 300cm.

• 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: 15233305
• Report Number: 2124215-2022-30432
• Device Sequence Number: 20447202
• Product Code: DQX
• UDI-Device Identifier: 08714729486886
• UDI-Public: 08714729486886
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 05/18/2025
• Device Model Number: 40375
• Device Catalogue Number: 40375
• Device Lot Number: 0029427008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2022
• Supplement Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 08/16/2022
• Supplement Report FDA Received Date: 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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