MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SAN JOSE FILTERWIRE EZ?; TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION

Model Number H749201001900

Device Problems Material Separation (1562); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 09/27/2013

Event Type  malfunction  

Event Description

It was reported that the tip of the device split in two.A 190 cm filterwire ez was selected to treat the target lesion.During preparation, it was noted that the tip of the filterwire was damaged and split in two.The procedure was completed with another of the same device.No patient complications were reported and the patient¿s status is fine.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device evaluated by manufacturer: device was retuned for analysis.A visual and microscopic examination was performed and found that the radiopaque distal tip of the protection wire was found slightly curved.It was not wavy, or stretched.The filter bag was found retracted into the delivery sheath with 4 mm of the nosecone exposed.The filter bag was successfully deployed and then retracted; the filter bag was observed to be in good condition and met specification.The peel away test was also performed successfully, no anomalies were observed.The inner wire was found broken at the distal solder joint, but not detached.Three mm of the wire was found protruding out of the coil.No discoloration was observed indicating overheating during soldering.Evidence of solder on the broken end of the wire was found, and no kinks or dents that could have weakened the wire were found.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

It was reported that the tip of the device split in two.A 190cm filterwire ez was selected to treat the target lesion.During preparation, it was noted that the tip of the filterwire was damaged and split in two.The procedure was completed with another of the same device.No patient complications were reported and the patient's status is fine.

• Brand Name: FILTERWIRE EZ?
• Type of Device: TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION
• Manufacturer (Section D): BOSTON SCIENTIFIC - SAN JOSE; 150 baytech drive; san jose CA 95134
• Manufacturer (Section G): BOSTON SCIENTIFIC - SAN JOSE; 150 baytech drive; san jose CA 95134
• Manufacturer Contact: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3634637
• MDR Text Key: 3984142
• Report Number: 2134265-2014-01077
• Device Sequence Number: 1
• Product Code: NFA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2015
• Device Model Number: H749201001900
• Device Catalogue Number: 20100-190
• Device Lot Number: 16114083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2013
• 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