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 06/24/2014

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on (b)(4) 2014.It was reported that there was difficulty deploying the filter.The stenosed target lesion was located in the carotid artery.A 190cm filterwire ez¿ was used to treat the target lesion.During procedure, when the lesion was reached, it was noted that the filter basket would not open.Procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.However, device analysis revealed a broken distal tip.

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by mfr.: the protection wire and the delivery sheath were returned inside a plastic bag, then inside a filterwire box.All were packed inside a plastic bag.The retrieval sheath was not returned.The peel away introducer and torquer were also returned.During the visual and microscopic examination of the returned device, the radiopaque distal tip of the protection wire was found wavy, stretched, and a approx.2.4 cm of the distal tip was found broken off.The break was not at a joint.The filter bag was found deployed, and observed to be in good condition and met specification.Blood was found on the inside of the delivery sheath.The protection wire was found exposed out or popped out of the slit in the delivery sheath from 7 cm to 11 cm, when measured from the distal end of the delivery sheath.The peel away introducer sheath was found attached to the sheath approximately at 102 cm, when measured from the distal end of the delivery sheath.The wire torquer was found attached to the protection wire at 141 cm, when measured from the distal tip of the protection wire.Protection wire was feed into the delivery sheath, and was able to perform the sheathing and unsheathing test 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: 3995176
• MDR Text Key: 16450076
• Report Number: 2134265-2014-04875
• 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
• Report Date: 07/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2015
• Device Model Number: H749201001900
• Device Catalogue Number: 20100-190
• Device Lot Number: 16545873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2013
• 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