MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

Model Number	1009665
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The additional 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 circumflex coronary artery.A 3x15mm nc trek balloon dilatation catheter (bdc) was being used with a balance middleweight (bmw) universal ii guide wire when resistance was felt between the devices during advancement and removal.The inner member of the bdc was noted to be separated, so all devices were removed together with the separated portion.No portion of the device remains in the anatomy.An unspecified guide wire and balloon were used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual, dimensional, and functional inspections were performed on the returned guide wire (gw) and the reported difficulty to advance and difficulty to remove were unable to be confirmed as the gw was able to advance and retract through the balloon catheter without any resistance noted.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents and/or complaints reported from this lot.Factors that may contribute to the difficulty to advance and difficulty to remove the guide wire, and cause resistance between the devices may include, but not limited to, manufacturing, device placement technique, delivery catheter support, anatomical conditions, inner diameter of guide wire lumen of guiding catheter, outer diameter of the guide wire, damage to the guide wire, damage to the delivery catheter, coagulation of blood or procedural contaminates.The investigation was unable to determine a conclusive cause for the reported difficulty to advance and difficulty to remove the guide wire through the balloon dilatation catheter.The noted stretched coils and bend on the core likely occurred during packing for return analysis.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12499172
• Report Number: 2024168-2021-08292
• Device Sequence Number: 17189839
• Product Code: DQX
• UDI-Device Identifier: 08717648118722
• UDI-Public: 08717648118722
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K072460
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2021

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 Expiration Date: 11/30/2021
• Device Model Number: 1009665
• Device Catalogue Number: 1009665
• Device Lot Number: 9120271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 09/20/2021
• Supplement Report FDA Received Date: 10/18/2021
• 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: 3X15 NC TREK BALLOON
• Patient Age: 74 YR