FDA Adverse Event Malfunction Summary report: N

FLOWIRE XT DOPPLER GUIDE WIRE

MDR report key: 1842401 · Received August 31, 2010

Report

Report Number: 2939520-2010-00037
Event Type: Malfunction
Date Received: August 31, 2010
Date of Event: August 4, 2010
Report Date: August 4, 2010
Manufacturer: VOLCANO CORPORATION
Product Code: DQX
PMA / PMN Number: K972764
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THERE WERE NO DEVIATIONS OR NON-CONFORMANCES THAT WOULD REASONABLY BE EXPECTED TO CONTRIBUTE TO THE REPORTED FAILURE. TO DATE, NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS FAILURE MODE WITHIN THIS LOT. THE RETURNED DEVICE WAS VISUALLY INSPECTED AND DAMAGE WAS OBSERVED. A KINK WAS OBSERVED IN THE PROXIMAL SHAFT (HYPOTUBE) APPROXIMATELY 32 CM FROM THE DISTAL END. STRETCHED COILS WERE OBSERVED JUST DISTAL OF THE PROXIMAL/DISTAL SHAFT TRANSITION AT APPROXIMATELY 30 CM. THE REPORTED KINK WAS CONFIRMED. BASED ON THESE INVESTIGATION RESULTS THE MOST LIKELY CAUSE OF THE KINK IS USER HANDLING. THE IFU PROVIDES A PRECAUTION AGAINST USING A DAMAGED WIRE. IT IS REPORTED, THE USER DISCONTINUED USE AND OBTAINED A NEW WIRE. THERE WERE NO REPORTS OF PT INJURY OR OTHER ADVERSE EVENT.

Description of Event or Problem · 1

A VOLCANO FLOWIRE XT DOPPLER GUIDE WIRE BECAME KINKED AND COULD NOT DELIVER THE BALLOON CATHETER TO THE LESION. THE PT WAS RE-WIRED AND THE SECOND WIRE FUNCTIONED AS INTENDED, ACCOMPLISHING THE IVUS PROCEDURE. NO PT INJURY OR ADVERSE EFFECT WAS REPORTED TO THE MANUFACTURER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	FLOWIRE XT DOPPLER GUIDE WIRE	DOPPLER GUIDE WIRE	DQX	VOLCANO CORPORATION	1400	011 01456

Patients

Seq	Age	Sex	Outcome	Treatment
1