MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRES

Catalog Number	1001782-HC
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that during a procedure to dilate a lesion in the superficial femoral artery, the 014 balance middleweight hydro guidewire distal portion separated 20cm before the distal tip.The separated portion was retrieved using a dilatation balloon.There was no adverse patient sequela and no clinically significant delay reported.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported material separation (tip and core) was confirmed.The reported difficult to remove could not be tested due to the device condition.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 incidents/complaints from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.Factors that may contribute to difficulty removing the balloon catheter over the guide wire include, but are not limited to, inner diameter of the catheter, outer diameter of the guide wire, device support, buildup of procedural contaminants, user technique, and/or damage to the catheter or guide wire.In this case, analysis of returned device noted the coils were compressed and misaligned.Misaligned coils would result in reduced clearance with the balloon catheter, possibly contributing to the reported difficulty during removal.Misaligned coils can occur due to interaction with the anatomy or an accessory device.Additionally, the separation of the core and tip was noted during catheter removal.It is possible that manipulation of the catheter, when resistance was encountered, contributed to the reported separation (tip and core).There is no indication of a product quality issue with respect to manufacture, design, or labeling.B5 - describe event or problem updated.
Additional Manufacturer Narrative
B1: adverse event removed.B2: required intervention removed and na added.H1: serious injury removed and malfunction added.H6: code 4641 removed and code 2199 added.
Event or Problem Description
Subsequent to the previously filed report, additional information was received that stated: the separation of the guide wire occurred during removal of the balloon which was over the guide wire.The separated portion remained in the balloon catheter and was simply removed with the balloon catheter.No intervention was required.No additional information was provided.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRES
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005737652; road no.2 km 58.0 cruce dávila; barceloneta PR 00617
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 18379030
• Report Number: 2024168-2023-14342
• Device Sequence Number: 7767367
• Product Code: DQX
• UDI-Device Identifier: 08717648025990
• UDI-Public: 08717648025990
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K021228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 1001782-HC
• Device Lot Number: 2051171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2023
• Supplement Date Received by Manufacturer: 12/19/2023; 02/26/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 01/10/2024; 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown