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

Model Number H749201003000

Device Problems Positioning Failure (1158); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that the filter basket failed to deploy.A 300 cm filterwire ez was used for treatment.During procedure, it was noted that the deployment sheath of the filter wire would not retract once the filter wire was positioned in the intended vessel.The physician then attempted to advance the wire to push the basket out of the deployment sheath.It was further noted that the filter basket would not deploy when the deployment sheath was pulled and the wire was pushed.The physician attempted to remove the filter wire through the catheter and further observed that the device would not retract through the guiding catheter.The procedure was completed with a different device.No patient complications were reported.However, device analysis revealed that the filter bag was torn off and was missing.

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for evaluation.The protection wire, the delivery sheath, the retrieval sheath, the introducer sheath and the valve dilator were returned inside a plastic bag, along with the empty packaging coil.All were then packed inside a double plastic bag.During the visual and microscopic examination of the returned device, the radiopaque distal tip of the protection wire was found curved, wavy, and had been stretched approximately 1 cm on its proximal portion.The filter bag was found retracted into the delivery sheath with 1.7 cm of the nosecone exposed and 6 mm of the filter bag exposed.Approximately 6 mm of the distal part of the filter bag was found torn off and missing.It was not returned with the rest of the device.The edges of the returned portion were observed to be uneven and jagged.Blood was found on the inside of the delivery sheath and inside the ripped filter bag.The protection wire was found exposed out of the slit in the delivery sheath from 6.6 cm to 12.3 cm, when measured from the distal end of the delivery sheath.The wire was found curved at 11 cm, and kinked at 195 cm, when measured from the distal tip of the protection wire.The sheath was found stretched.The wire was also found exposed out of delivery sheath¿s slit again at approximately 96.5cm to 97.5 cm, when measured from the distal tip of the protection wire.The sheath was also found damaged at 103 cm to 105 cm, when measured from the distal end of the delivery sheath.The sheath was found curved and kinked at approximately 148 cm, when measured from the distal end of the delivery sheath.Sheathing or unsheathing test was not performed due to the kinks and damages noted on the device indicating that there have been some difficulty in removing the device.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: 3901540
• MDR Text Key: 4649274
• Report Number: 2134265-2014-03740
• 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
• Report Date: 06/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2015
• Device Model Number: H749201003000
• Device Catalogue Number: 20100-300
• Device Lot Number: 16424424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2013
• 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