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

Model Number H749201051900

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2013

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on (b)(4) 2014 it was reported that the device was found faulty.A 190 cm filterwire ez was selected for a carotid angioplasty procedure.During preparation, when the doctor removed the packing material for material inspection it was noted that the wire was coming out of the slit in the delivery sheath.The procedure was completed with another of the same device.No patient complications were reported and the patient's status is stable.However, device analysis revealed that the loop legs were found exposed out the wall of the delivery sheath at the distal gray shaded area.

Manufacturer Narrative

Device evaluated by manufacturer.The device was returned for analysis.It was observed that during the visual and microscopic examination, the radiopaque distal tip of the protection wire was found wavy and had been stretched approximately 8 mm on its proximal portion.The filter bag was found retracted into the delivery sheath with 14 mm of the nosecone exposed and 4 mm of the filter bag exposed.No trace of blood was found on the device.The loop legs were found exposed out the wall of the delivery sheath at the distal gray shaded area from 14 mm to 16 mm, and the sheath was found deformed at 2.8 cm, when measured from the distal tip of the delivery sheath.Manually removed the filter bag, and upon visual inspection, the filter bag was found in good condition and met specifications.There were no sharp edges or protrusions on the loop coil near the junction of the loop legs and the beginning of the reverse winding.As expected, adhesive covered the top end of the coil and bottom of the coil before the spinner stop.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).

• 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: 3603128
• MDR Text Key: 4192020
• Report Number: 2134265-2014-00140
• Device Sequence Number: 1
• Product Code: NFA
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 01/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2015
• Device Model Number: H749201051900
• Device Catalogue Number: 20105-190
• Device Lot Number: 16050688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2013
• 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: 85 YR