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

Model Number M001509100

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/08/2016

Event Type  malfunction  

Manufacturer Narrative

Age at the time of event: 18 years and older.(b)(4).Device evaluated by mfr.: the device was returned for evaluation.The outer diameter of the guide wire meets specification.The coating was inconsistent, peeling and rough throughout the length of the guide wire.A non-bsc catheter was received; however, it could not be used because of the damage it sustained in the id from removing the guide wire.A non bsc microcatheter was used for testing purposes.The guide wire and the microcatheter were both hydrated with fluid.The wire was loaded into the microcatheter and advanced through the full-length of the catheter without encountering any unusual resistance.There was evidence of product quality deficiencies contributing to the reported difficulty.The reported events were confirmed due to the wire being stuck in the returned device.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 Description

Reportable based on analysis completed on 09jun2016.It was reported that the guide wire became difficult to insert.The 90% stenosed target lesion was located in a moderately tortuous and moderately calcified arterial shunt.Upon introduction, inside patient, it was noted that the guide wire was unable to pass through a balloon catheter.The procedure was completed with a different device.No patient complications reported and the patient's condition was good.However, device analysis revealed peeled coating.

• Brand Name: FATHOM¿ -16
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5775366
• MDR Text Key: 48963339
• Report Number: 2134265-2016-05749
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• PMA/PMN Number: K111485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/09/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: M001509100
• Device Catalogue Number: 50-910
• Device Lot Number: 18684337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2016
• Initial Date FDA Received: 07/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1