MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDEWIRE; WIRE, GUIDE, CATHETER

Catalog Number 1009660J

Device Problems Break (1069); Disconnection (1171); Looping (1370); Difficult to Advance (2920)

Patient Problem No Information (3190)

Event Date 05/14/2014

Event Type  malfunction  

Event Description

The patient was having cardiac catheterization.The right radial artery was cannulated, then upon advancing the wire and the ikari catheter, the cardiologist noted that there was a loop in the left radial artery.He negotiated the loop with a balance middle weight (bmw)wire distally.He tried to advance the guiding catheter over a 2.5 mm balloon, but due to the tortuosity of the loop he was not able to advance the equipment.He retrieved the balloon and wire, but noticed that the wire was disconnected in the middle at the transition site and only the distal end of the wire came out.The other end was stuck into the brachial artey.He advanced a whisper wire to the level of the brachial artery, again through the loop, hoping to snare the disconnected wire, but again the whisper wire broke at the level of the brachial artery.He was able to snare the whisper wire with a snare.He then had to cannulate the femoral artery, advance a snare, and capture the bmw wire.Both broken wires were successfully removed.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDEWIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 3200 lakeside drive; santa clara, ca 95054 CA 95054
• MDR Report Key: 3871360
• MDR Text Key: 17157359
• Report Number: 3871360
• Device Sequence Number: 1
• Product Code: DQX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/21/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 1009660J
• Device Lot Number: 4032571
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/21/2014
• Device Age: 2 MO
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NAMIC 3 PORT MANIFOLD, TERUMO MEDICAL CORP.6 FR.; GLIDESHEATH SLENDER AND 6 FR. HEARTRAIL III; COOK MEDICAL 18 G. ENTRY NEEDLE, BOSTON SCIENTIFIC
• Patient Age: 70 YR
• Patient Weight: 82