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

Model Number H749201001900

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2014

Event Type  malfunction  

Event Description

Reportable based on analysis completed on (b)(4) 2014.It was reported that the device failed to deploy.The 95% stenosed, 12mm in length, 8mm in diameter target lesion was located in the severely tortuous and severely calcified left internal carotid artery.The lesion had a bend over between 45 degree but less than 90 degree.A 190cm filterwire ez¿ was used for a carotid artery stenting procedure.During procedure, it was noted that the filter could not release normally.The physician removed the device and completed the procedure with another of the same device.There were no patient complications reported and the patient's status was stable.However, device analysis revealed that the filter bag was torn into 2 pieces.

Manufacturer Narrative

Device evaluate by mfr.: investigation completed.The device was returned for evaluation.The device was returned without the packaging that contained the batch information.The protection wire and the delivery sheath were returned inside a plastic bag.The retrieval sheath was not returned.During visual and microscopic examination of the returned device, the radiopaque distal tip of the protection wire was found curved; it was not damaged, wavy, or stretched.The filter bag was found deployed, however, it was found torn into 2 pieces.Both pieces were still attached to the device and no missing or completely detached pieces were found.The tear was found at the tip of the filter bag and the material is still attached to the adhesive.Blood was found on the inside of the delivery sheath.Sheathing/unsheathing test was performed successfully.The filter bag was successfully retracted and then deployed.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).

• 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: 4055708
• MDR Text Key: 17278440
• Report Number: 2134265-2014-05365
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2015
• Device Model Number: H749201001900
• Device Catalogue Number: 20100-190
• Device Lot Number: 16305448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2013
• 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
• Patient Age: 69 YR
• Patient Weight: 63