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	07/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guidewire unraveled and the distal tip detached.A 014/300/sst platinum plus guidewire was used in the non-tortuous, mildly calcified superficial femoral and popliteal arteries for imaging.During the procedure, the doctor noticed the guidewire was unraveling and decided to remove the guidewire, with the ivus device.After removing everything, it was noticed on the back table, that the distal end of the guidewire was detached.The doctor flushed the catheter and the detached tip of the guidewire, flushed out.The procedure was completed with a different device.There were no patient complications 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: 15229098
• Report Number: 2124215-2022-29314
• Device Sequence Number: 14955795
• 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
• Report Date (Section B): 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 08/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown