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

Model Number	1011882
Medical Device Problem Codes	Peeled/Delaminated (1454); Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2022
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.
Event or Problem Description
It was reported that the procedure was to treat a heavily tortuous lesion in the proximal right coronary artery (prca).A 014 ht bmw elite guide wire (gw) was being advanced through the guide catheter when resistance was felt between the guide wire and the guide catheter.The guide wire was removed and once outside the patient anatomy, segments of the guide wire felt and looked like it had been shaved.Imaging showed no guide wire coating in the anatomy and no foreign material was removed from the patient.A new bmw guide wire was used to successfully complete the procedure.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual, dimensional, and functional inspection was performed on the returned device.The reported difficult to advance was confirmed.The reported peeled/delaminated could not be confirmed; however, it is possible that the scratched teflon coating noted during return analysis may have been inadvertently noted as peeled/delaminated.The reported difficult to remove could not be tested as it was based on operational context.Additionally, it was noted that coils were misaligned, teflon was scratched and solder was separated.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.In this case, it is possible that inadvertent damage to the guide wire, such as the misaligned coils noted during return analysis, may have contributed to an interaction between the guide wire and guide catheter, resulting in the reported difficult to advance and subsequent difficult to remove.Manipulation of the guide wire during its interaction with the guide catheter may have contributed to the noted scratched teflon and material separation (solder); however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT ELITE 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 # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 15874928
• Report Number: 2024168-2022-11970
• Device Sequence Number: 20205249
• Product Code: DQX
• UDI-Device Identifier: 08717648144820
• UDI-Public: 08717648144820
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K103101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2023

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: 02/29/2024
• Device Model Number: 1011882
• Device Catalogue Number: 1011882
• Device Lot Number: 2032861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2022
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2022
• 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
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 65 KG