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

Model Number	81720
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Returned product consisted of a fathom guidewire.The shaft was inspected for damage.The shaft was fractured 9.5cm from the tip.The device was not completely separated as the inner coil was still attached.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.
Event or Problem Description
It was reported that wire was separated.A 140x25cm fathom-16 was selected for use.During the procedure, the floppy tip of the device was found to be separated from the wire's body.The device was successfully removed from the patient with the catheter with no patient consequences.The procedure was completed with another of same device.No patient complications were 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: 8394712
• Report Number: 2134265-2019-02095
• Device Sequence Number: 13501016
• Product Code: DQX
• UDI-Device Identifier: 08714729764410
• UDI-Public: 08714729764410
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 03/06/2019

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: 10/14/2021
• Device Model Number: 81720
• Device Catalogue Number: 81720
• Device Lot Number: 22794952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 03/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1