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

Model Number	2400
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire fracture occurred.Upon unpacking a guidewire break was observed with a 018 st 180cm platinum plus guidewire.The procedure was completed with another of same device.No patient complications were reported.
Additional Manufacturer Narrative
The unit was returned with its original pouch overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The wire was inspected visually and microscopically and the spring tip was noted to be damaged (stretched, kinked and unraveled).Microscopic inspection also revealed the wire was broken at the distal tip section.
Event or Problem Description
It was reported that guidewire fracture occurred.Upon unpacking a guidewire break was observed with a 018 st 180cm platinum plus guidewire.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
• MDR Report Key: 11942571
• Report Number: 2134265-2021-07273
• Device Sequence Number: 4176073
• Product Code: DQX
• UDI-Device Identifier: 08714729145110
• UDI-Public: 08714729145110
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K942453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2021

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: 06/25/2021
• Device Model Number: 2400
• Device Catalogue Number: 2400
• Device Lot Number: 0022304012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1