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

Model Number M001509100

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 06/14/2016

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: late 60s.(b)(4).Device evaluated by mfr: the device was returned for analysis.Initial magnified inspection of the guidewire tip showed no foreign substance or anything that could represent a foreign matter.The outer diameter (od) met the specification.The coating was uniform and consistent throughout the length of the wire.The micro-catheter used in the clinical event was not received.A 0.18 rubicon micro catheter was used for testing purposes.The inner diameter of the micro-catheter was measured with a calibrated pin gauge set and measured.019¿.The wire and micro-catheter were both hydrated with fluid.The wire was loaded into the micro-catheter and advanced through the full-length of the catheter without encountering any unusual resistance up until the kink.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).

Event Description

It was reported that a foreign material was noted at the tip of the guidewire.A 180 x 25cm fathom - 16 was used during a y-90 procedure.During preparation, the guidewire was unable to be inserted into an unknown microcatheter.After several tries, it was noted that the tip of the guidewire had a ball of extra material.The physician tried to remove the extra material using his fingers.After several attempts, the extra material was removed.The procedure was completed with another of the same device.No patient complications were reported.

• 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: 5792726
• MDR Text Key: 49497447
• Report Number: 2134265-2016-06701
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: M001509100
• Device Catalogue Number: 50-910
• Device Lot Number: 19112002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2016
• 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