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

Model Number	81720
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/18/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coating of the device broke.A 180x35cm fathom 16 was selected for use.A break of the coating at the tip of the device was noted upon opening the device.The procedure was completed with another of same device.No patient complications were reported.
Event or Problem Description
It was reported that the coating of the device broke.A 180x35cm fathom 16 was selected for use.A break of the coating at the tip of the device was noted upon opening the device.The procedure was completed with another of same device.No patient complications were reported.The device was returned for analysis.The catheter shaft was inspected for damage.No damage was noticed on the shaft or the shafts coating.Microscopic evaluation of the tip showed a slight fracture located 1.8cm from the tip.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

• 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: 7979727
• Report Number: 2134265-2018-62072
• Device Sequence Number: 19170646
• Product Code: DQX
• UDI-Device Identifier: 08714729762560
• UDI-Public: 08714729762560
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K170636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2018

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: 06/18/2021
• Device Model Number: 81720
• Device Catalogue Number: 81720
• Device Lot Number: 0022271860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Initial Date Received by Manufacturer: 10/05/2018
• Supplement Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 11/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1