FILTERWIRE EZ EMOBLIC PROTECTION SYSTEM

Report

Report Number: 2134265-2010-04815
Event Type: Malfunction
Date Received: October 18, 2010
Date of Event: September 21, 2010
Report Date: September 21, 2010
Manufacturer: BOSTON SCIENTIFIC - SAN JOSE
Product Code: NFA
PMA / PMN Number: K061332
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CN
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

DEVICE EVALUATED BY MANUFACTURER: THE PROTECTION WIRE WAS RETURNED INSIDE THE DELIVERY SYSTEM. PRODUCT ANALYSIS REVEALED THE DISTAL TIP OF THE PROTECTION WIRE WAS WAVY. THE FILTER BAG WAS DEPLOYED FROM THE RETRIEVAL SHEATH; ONLY THE LEG ON THE LOOP COIL WAS INSIDE THE RETRIEVAL SHEATH. THE FILTER BAG WAS INTACT AND VERIFIED NORMAL. HOWEVER, DRIED BLOOD AND DEBRIS WAS SEEN INSIDE THE FILTER BAG. THE PROTECTION WIRE WAS KINKED AT APPROXIMATELY 49.1 CM MEASURED FROM THE DISTAL TIP OF THE PROTECTION WIRE. THE DISTAL TIP OF THE RETRIEVAL SHEATH VERIFIED NORMAL, AND THE MARKER BAND WAS INTACT. DRIED BLOOD WAS SEEN INSIDE THE RETRIEVAL SHEATH. THE RETRIEVAL SHEATH WAS KINKED AT APPROXIMATELY 43.5 CM, AND 117.0 CM RESPECTIVELY MEASURED FROM THE DISTAL TIP OF THE RETRIEVAL SHEATH. THE KINK ON THE PROTECTION WIRE AT 49.1 CM CORRESPONDS TO THE KINK ON THE RETRIEVAL SHEATH AT 43.5 CM. USING A WIRE TORQUER, IT WAS NOT POSSIBLE TO DEPLOY THE FILTER BAG FROM THE RETRIEVAL SHEATH, DUE TO THE DRIED BLOOD INSIDE THE RETRIEVAL SHEATH. APPROXIMATELY 2 MM OF THE FILTER BAG WAS OUTSIDE THE RETRIEVAL SHEATH. 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).

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A PERCUTANEOUS CAROTID ARTERY STENTING TREATMENT PROCEDURE, THE FILTER WIRE DID NOT FULLY RETRACT INTO THE RETRIEVAL SHEATH. THE PATIENT WAS DIAGNOSED WITH INTERNAL CAROTID ARTERY STENOSIS. IT WAS NOTED THAT AFTER PREPARING THE FILTERWIRE EZ ACCORDING THE MANUAL INSTRUCTION AND DEPLOYING THE DEVICE ON THE OPTIMAL POSITION THE PHYSICIAN IMPLANTED THE STENT SUCCESSFULLY. WHEN THE PHYSICIAN WAS ADVANCING THE RETRIEVAL SHEATH HE FELT THERE WAS A STRONG RESISTANCE BETWEEN THE WIRE AND THE SHEATH, THEN HE FOUND THE WIRE WAS KINKED. THE FILTER WIRE AT THIS POINT WAS WITHDRAWN FROM THE PATIENT, NOT COMPLETELY RETRACTED BACK INTO THE RETRIEVAL SHEATH. THERE WAS NO REMOVAL DIFFICULTY, BUT A 10-15 MINUTE DELAY IN THE PROCEDURE WAS NOTED. THE PATIENT CONDITION WAS LISTED AS STABLE.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A PERCUTANEOUS CAROTID ARTERY STENTING TREATMENT PROCEDURE, THE FILTER WIRE DID NOT FULLY RETRACT INTO THE RETRIEVAL SHEATH. THE PATIENT WAS DIAGNOSED WITH INTERNAL CAROTID ARTERY STENOSIS. IT WAS NOTED THAT AFTER PREPARING THE FILTERWIRE EZ ACCORDING THE MANUAL INSTRUCTION AND DEPLOYING THE DEVICE ON THE OPTIMAL POSITION THE PHYSICIAN IMPLANTED THE STENT SUCCESSFULLY. WHEN THE PHYSICIAN WAS ADVANCING THE RETRIEVAL SHEATH HE FELT THERE WAS A STRONG RESISTANCE BETWEEN THE WIRE AND THE SHEATH, THEN HE FOUND THE WIRE WAS KINKED. THE FILTER WIRE AT THIS POINT WAS WITHDRAWN FROM THE PATIENT, NOT COMPLETELY RETRACTED BACK INTO THE RETRIEVAL SHEATH. THERE WAS NO REMOVAL DIFFICULTY, BUT A 10-15 MINUTE DELAY IN THE PROCEDURE WAS NOTED. THE PATIENT CONDITION WAS LISTED AS STABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	FILTERWIRE EZ EMOBLIC PROTECTION SYSTEM	TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION	NFA	BOSTON SCIENTIFIC - SAN JOSE	H749201051900	0000932003

Patients

Seq	Age	Sex	Outcome	Treatment
1	59 YR		Other