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

Model Number M001509100

Device Problems Difficult to Insert (1316); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 01/16/2014

Event Type  malfunction  

Event Description

It was reported that a foreign substance was noted at the tip of the wire.The target lesion was located at an unspecified artery.A 16.016 fathom wire was selected for a embolotherapy treatment procedure.During preparation, it was noted that a silicone substance was seen at the tip of the device thus making the wire unable to be loaded in the renegade catheter.The procedure was completed with another of the same device.No patient complications were reported.

Event Description

It was reported that a foreign substance was noted at the tip of the wire.The target lesion was located at an unspecified artery.A 16.016 fathom wire was selected for a embolotherapy treatment procedure.During preparation, it was noted that a silicone substance was seen at the tip of the device thus making the wire unable to be loaded in the renegade catheter.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device evaluated by mfr.The device was returned for analysis.There was no damage to the guidewire.Microscopic inspection of the tip did not reveal any irregularities or damage.The outer diameter of the guidewire was measured with a calibrated snap gage; the maximum outer diameter of the guidewire was.0160", which meets specification.Because the renegade used in the clinical event was not received with the fathom guidewire a rubicon 18 catheter was used for functional testing.The fathom guidewire was advanced through the rubicon with no unusual resistance.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).

• 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: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3621649
• MDR Text Key: 4136183
• Report Number: 2134265-2014-00407
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K111485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/16/2014

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: 10/30/2016
• Device Model Number: M001509100
• Device Catalogue Number: 50-910
• Device Lot Number: 16502200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2014
• Initial Date FDA Received: 02/11/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2013
• 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