MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE FATHOM¿ -16; WIRE, GUIDE, CATHETER

Model Number	M001509000
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr.: device was not returned for evaluation.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
Event or Problem Description
It was reported that guide wire coating issue occurred.The target lesion was located in the hepatic artery.A 140x25cm fathom" -16 guide wire was selected for use.During procedure, it was noted that the wire was unable to move forward.The device was pulled back and it was found out that the surface of the wire was harsh and coating looked like it was almost taken off, not completely detached.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

• Brand Name: FATHOM¿ -16
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 6107010
• Report Number: 2134265-2016-10050
• Device Sequence Number: 889507
• Product Code: DQX
• UDI-Device Identifier: 08714729764410
• UDI-Public: (01)08714729764410(17)20190430(10)19174636.
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K111485
• 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
• Report Date (Section B): 10/20/2016

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: 04/30/2019
• Device Model Number: M001509000
• Device Catalogue Number: 50-900
• Device Lot Number: 19174636
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2016
• Initial Report FDA Received Date: 11/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR