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 04/01/2015

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 06may2015.It was reported that the device failed to deploy.The stenosed target lesion was located in the left carotid artery.A 190cm filterwire ez¿ was selected and advanced to treat the target lesion.During procedure, after the device reached the lesion, it was noted that the device would not deploy.There were no patient complications reported and the patient's status was stable.However, device analysis revealed the spring tip is broken and missing.

Manufacturer Narrative

(b)(4).The device was returned for analysis.The unit returned has the distal tip damaged.Visual inspection observed that the wire was found exposed through sheath slit, therefore, sheathing and unsheathing test could not be performed.Moreover, the wire is bent and the spring tip was partially broken (coilwire and corewire).The filter bag was observed to be in good condition and met specification.All the outer diameter (ods) taken and all of them are according specifications.The most distal section of the spring tip is broken and missing.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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4801836
• MDR Text Key: 5929556
• Report Number: 2134265-2015-03218
• 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: 05/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2016
• Device Model Number: H749201001900
• Device Catalogue Number: 20100-190
• Device Lot Number: 16891089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2014
• 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