MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE EXTRA SPORT; WIRE, GUIDE, CATHETER

Device Problems Material Fragmentation (1261); Difficult to Insert (1316); Failure to Advance (2524); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/22/2019

Event Type  malfunction  

Event Description

A sport wire fractured and the distal tip embolized into the left circumflex ostium when doctor advanced the stent beyond the guide.The sport wire was being used as a buddy wire to get a 2.5 x 15 mm balloon to advance down the left anterior descending (lad).This appeared to be about a 30 mm long fragment that was coiled.The doctor used a loop initially, but the catheter of the loop was too short to advance into the coronary.A flower shaped loop was advanced, but would not go beyond the fragment and kept backing the guide out so the doctor advanced a new sport wire beyond the fragmented tip and this acted as a buddy wire to allow the loop to advance beyond the fragment.After twisting the loop several times the doctor realized it was moving the fragment, so the doctor pulled the loop into it's guide as far as possible then was able to pull the wires back into the guide and remove the guide.The doctor went back with a 6cm (6fr) guide and was able to place the stents and use the non-compliant balloon to dilate the lad.Per staff, the device packaging was thrown away.The lot numbers aren't available.Per staff device packaging thrown away.

• Brand Name: HI-TORQUE EXTRA SPORT
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 100 abbott park road; d-03q3, ap52-1; abbott park IL 60064
• MDR Report Key: 8615183
• MDR Text Key: 145223040
• Report Number: 8615183
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/14/2019,05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/14/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/16/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 29200 DA