MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FATHOM -16; WIRE, GUIDE, CATHETER

Model Number	81720
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a guidewire fracture occurred.A 180x35cm fathom -16 guidewire was selected for use.During preparation, it was noted that the fathom wire was split.The physician revealed that the same issue happened twice.No patient complications reported.

• Brand Name: FATHOM -16
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9744596
• Report Number: 2134265-2020-01908
• Device Sequence Number: 2483113
• Product Code: DQX
• UDI-Device Identifier: 08714729762560
• UDI-Public: 08714729762560
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K170636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/24/2020

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: 10/02/2022
• Device Model Number: 81720
• Device Catalogue Number: 81720
• Device Lot Number: 0024537040
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 02/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1