MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FATHOM -14; WIRE, GUIDE, CATHETER

Model Number	81725
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/21/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tip of the wire was fractured.The target lesion was located in the intracranial artery.A 300cm x 10 cm fathom -14 wire was selected for use.At the end of the procedure, when the device was removed from the patient's body, it was noted that the tip of the wire became kinked and fractured.The procedure was completed with another device.No patient complications were reported and the patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The guidewire shaft was inspected for damage.The shaft showed 1 kink located 86.5cm from the tip.The device showed that the shaft/tip was fractured.The fracture was located at 11.5cm from the tip.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 tip of the wire was fractured.The target lesion was located in the intracranial artery.A 300cm x 10 cm fathom -14 wire was selected for use.At the end of the procedure, when the device was removed from the patient's body, it was noted that the tip of the wire became kinked and fractured.The procedure was completed with another device.No patient complications were reported and the patient was stable post procedure.

• Brand Name: FATHOM -14
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9328072
• Report Number: 2134265-2019-13877
• Device Sequence Number: 16768772
• Product Code: DQX
• UDI-Device Identifier: 08714729801047
• UDI-Public: 08714729801047
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2020

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: 02/10/2022
• Device Model Number: 81725
• Device Catalogue Number: 81725
• Device Lot Number: 0023328032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Initial Date Received by Manufacturer: 10/25/2019
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 02/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 64