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

Model Number	39975
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	05/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire detachment occurred.There were two 3 025/180 platinum plus guidewires used during a peripheral procedure.However, both devices were separated 5 cm from tip.The procedure was completed successfully.There were no patient complications reported.
Event or Problem Description
It was reported that guidewire detachment occurred.There were two 025/180 platinum plus guidewires used during a peripheral procedure.However, both devices were separated 5 cm from tip.The procedure was completed successfully.There were no patient complications reported.It was further reported that the 90% stenosed target lesion was located in a mildly tortuous and non-calcified vessel in the left kidney with an indwelling balloon expandable uncovered stent in the left renal ostium that had been placed and partially mangled by another proceduralist a few months earlier.Irregular fluoroscopic appearance prompted the removal of the wires, at which time the separation was noticed.The devices were carefully withdrawn from the inside of a high-flow renegade microcatheter under fluoroscopic guidance to ensure that the tip was not left behind inside the patient.

• 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: 14782590
• Report Number: 2134265-2022-06596
• Device Sequence Number: 20096370
• Product Code: DQX
• UDI-Device Identifier: 08714729114581
• UDI-Public: 08714729114581
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2022

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: 10/31/2024
• Device Model Number: 39975
• Device Catalogue Number: 39975
• Device Lot Number: 0028304980
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 06/22/2022
• Supplement Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2021
• 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