FILTERWIRE EZ?

Report

Report Number: 2134265-2014-04718
Event Type: Injury
Date Received: August 5, 2014
Date of Event: July 14, 2014
Report Date: July 14, 2014
Manufacturer: BOSTON SCIENTIFIC - SAN JOSE
Product Code: NFA
PMA / PMN Number: K061332
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SG
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

AGE AT THE TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

Additional Manufacturer Narrative · 1

DEVICE EVALUATED BY MFR.: INVESTIGATION COMPLETED. THE DEVICE WAS RETURNED FOR ANALYSIS. THE DELIVERY SHEATH AND THE PROTECTION WIRE WERE RETURNED INSIDE A DOUBLE PLASTIC BAG. THE RETRIEVAL SHEATH WAS NOT RETURNED. DURING THE VISUAL AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE, THE RADIOPAQUE DISTAL TIP OF THE PROTECTION WIRE WAS FOUND CURVED, AND BENT. APPROXIMATELY 10 CM OF THE DISTAL PORTION OF THE WIRE WAS STICKING OUT OF THE DELIVERY SHEATH, WHEN MEASURED FROM THE DISTAL TIP OF THE PROTECTION WIRE. BLOOD WAS FOUND ON THE INSIDE OF THE DELIVERY SHEATH. THE WIRE WAS FOUND KINKED APPROXIMATELY AT 113.5 CM, 115 CM, AND 125 CM, WHEN MEASURED FROM THE DISTAL TIP OF THE PROTECTION WIRE. SHEATHING/UNSHEATHING TEST WAS DONE SUCCESSFULLY. THE FILTER BAG WAS SUCCESSFULLY RETRACTED AND THEN DEPLOYED; THE FILTER BAG WAS OBSERVED TO BE IN GOOD CONDITION AND MET SPECIFICATION. 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 ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

Description of Event or Problem · 1

SAME CASE AS MDR ID: 2134265-2014-04717. IT WAS REPORTED THAT PATIENT'S BLOOD PRESSURE DROPPED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 20MM IN LENGTH, GRAFT ANASTOMOSIS, ECCENTRIC, 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS, MODERATELY CALCIFIED AND 4.0MM IN DIAMETER PROXIMAL SAPHENOUS VEIN GRAFT (SVG) TO LEFT ANTERIOR DESCENDING ARTERY (LAD). A 6F X 3.5MM UNSPECIFIED GUIDE CATHETER WAS USED. AFTER A NON BSC GUIDE WIRE CROSS THE LESION A 190CM FILTERWIRE EZ¿ WAS SELECTED TO BE ADVANCED TO THE TARGET LESION. DURING PROCEDURE, THE PHYSICIAN ATTEMPTED TO PLACE THE DEVICE INTO THE GUIDE CATHETER AND TO THE PROXIMAL PART OF THE SVG. HOWEVER, A DROP IN THE PATIENT'S BLOOD PRESSURE WAS NOTED. THE PHYSICIAN REMOVED THE DEVICE FROM THE PATIENT AND THE BLOOD PRESSURE WENT BACK TO NORMAL. THE PHYSICIAN ATTEMPTED TO DEPLOY THE DEVICE IN A DISH OF SALINE, IT WAS THEN NOTED THAT THERE WAS DIFFICULTY DEPLOYING THE FILTER. A 4.0 X 20MM SYNERGY STENT WAS IMPLANTED AND LESION WAS POST DILATED USING A 4.0X15MM QUANTUM APEX BALLOON CATHETER. PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

Description of Event or Problem · 1

SAME CASE AS MDR ID: 2134265-2014-04717. IT WAS REPORTED THAT PATIENT'S BLOOD PRESSURE DROPPED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 20MM IN LENGTH, GRAFT ANASTOMOSIS, ECCENTRIC, 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS, MODERATELY CALCIFIED AND 4.0MM IN DIAMETER PROXIMAL SAPHENOUS VEIN GRAFT (SVG) TO LEFT ANTERIOR DESCENDING ARTERY (LAD). A 6F X 3.5MM UNSPECIFIED GUIDE CATHETER WAS USED. AFTER A NON BSC GUIDE WIRE CROSS THE LESION A 190CM FILTERWIRE EZ¿ WAS SELECTED TO BE ADVANCED TO THE TARGET LESION. DURING PROCEDURE, THE PHYSICIAN ATTEMPTED TO PLACE THE DEVICE INTO THE GUIDE CATHETER AND TO THE PROXIMAL PART OF THE SVG. HOWEVER, A DROP IN THE PATIENT'S BLOOD PRESSURE WAS NOTED. THE PHYSICIAN REMOVED THE DEVICE FROM THE PATIENT AND THE BLOOD PRESSURE WENT BACK TO NORMAL. THE PHYSICIAN ATTEMPTED TO DEPLOY THE DEVICE IN A DISH OF SALINE, IT WAS THEN NOTED THAT THERE WAS DIFFICULTY DEPLOYING THE FILTER. A 4.0 X 20MM SYNERGY STENT WAS IMPLANTED AND LESION WAS POST DILATED USING A 4.0X15MM QUANTUM APEX BALLOON CATHETER. PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
458277	FILTERWIRE EZ?	TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION	NFA	BOSTON SCIENTIFIC - SAN JOSE	H749201003990	15512568

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other	GUIDE WIRE: BMW WIRE