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

Model Number H749201001900

Device Problems Break (1069); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/08/2014

Event Type  malfunction  

Event Description

It was reported that wire on the filter bag broke.The stenosed target lesion was located in the carotid artery.A 190cm filterwire ez¿ was selected to treat the target lesion.During the procedure, the filterwire could not cross the lesion due to the condition of the vessel.The wire on the filter bag was broken.The physician pulled the device back and removed it outside of the patient.The procedure was not completed.No patient complications reported and the patient's status was stable.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device evaluated by mfr.: the device was returned or analysis.During visual and microscopic examination of the returned device, the radiopaque distal tip of the protection wire was found curved, kinked and wavy.The filter bag was found retracted into the delivery sheath with 4 mm of the nosecone exposed.No broken or detached wire was found.Product analysis only confirmed distal tip damage.Blood was found on the inside of the delivery sheath.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 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

It was reported that wire on the filter bag broke.The stenosed target lesion was located in the carotid artery.A 190cm filterwire ez¿ was selected to treat the target lesion.During the procedure, the filterwire could not cross the lesion due to the condition of the vessel.The wire on the filter bag was broken.The physician pulled the device back and removed it outside of the patient.The procedure was not completed.No patient complications reported and the patient's status was stable.

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4060791
• MDR Text Key: 4905825
• Report Number: 2134265-2014-05504
• Device Sequence Number: 1
• Product Code: NFA
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K061332
• 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: 08/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2015
• Device Model Number: H749201001900
• Device Catalogue Number: 20100-190
• Device Lot Number: 16308866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2013
• 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