MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE ADVANCE GUIDE WIRE

Model Number	1044586
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual and dimensional analysis was performed on the returned device.The cause of the difficult to remove is confirmed.The lot history record (lhr) for this product could not be reviewed a query of the complaint handling database for the reported device could not be conducted because the lot number was not reported.Based on the information provided, the investigation determined the reported difficult to remove was due to case circumstances.In this case, the clearance between the guide wire lumen of the bdc and the guide wire was reduced causing the devices to become stuck together.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device the nc trek device referenced is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the left anterior descending artery.A 4.5x20mm nc trek rx balloon dilatation catheter (bdc) was prepared per instructions for use and with a 50/50 ratio contrast for post-dilatation.The bdc was inflated two times at 14 atmospheres; however, it was noted that the balloon did not deflate after the second inflation.A negative was held for 10 seconds, but the balloon only partially deflated.The bdc became caught on the non-abbott guide wire.All devices were removed as a unit.The procedure was successfully completed with an unspecified balloon catheter.There were no adverse patient effects and no clinically significant delay in the procedure.Additional information received indicating that the guide wire that became caught in the bdc was an abbott vascular ht advance lite.No additional information was provided.

• Brand Name: HI-TORQUE ADVANCE GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10892314
• Report Number: 2024168-2020-09855
• Device Sequence Number: 4001681
• Product Code: DQX
• UDI-Device Identifier: 08717648014468
• UDI-Public: 08717648014468
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K060449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1044586
• Device Catalogue Number: 1044586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON CATHETER: 4.5X20MM NC TREK
• Patient Age: 61 YR