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

Model Number H749201003990

Device Problem Positioning Failure (1158)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 07/14/2014

Event Type  Injury  

Event Description

Same case as mdr id: 2134265-2014-04718.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.

Manufacturer Narrative

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).

Event Description

Same case as mdr id: 2134265-2014-04718.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.

Manufacturer Narrative

Device evaluated by mfr.: investigation completed.The device was received for evaluation.The delivery sheath and the protection wire were returned inside a head bag, then 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 slightly curved; it was not damaged or stretched.Approximately 15 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.Sheathing/unsheathing test was performed 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).

• 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: 3981141
• MDR Text Key: 4886798
• Report Number: 2134265-2014-04717
• Device Sequence Number: 1
• Product Code: NFA
• Combination Product (y/n): N
• Reporter Country Code: SG
• 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,Followup
• Report Date: 07/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2016
• Device Model Number: H749201003990
• Device Catalogue Number: 20100-399
• Device Lot Number: 16662666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2014
• 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
• Treatment: GUIDE WIRE: BMW WIRE
• Patient Outcome(s): Other