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

Model Number	1009660J
Medical Device Problem Codes	Material Separation (1562); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2023
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 the additional ht-bmw universal device referenced is filed under separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat the anterior descending coronary artery.A balance middleweight universal guide wire was advanced without resistance; however, separated in the proximal portion when attempting to advance through a guide catheter.There was no resistance during removal and the separated portion was simply withdrawn without issue.Another balance middleweight universal guide wire was advanced without resistance but fractured in the proximal portion.There was no resistance during removal and the guide wire was simply withdrawn without issue.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
Subsequent to the initially filed reports, returned device analysis identified that there was no break or separation on either wire as reported.The account stated that stretched coils are what the account reported as broken and separated.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported stretched coils were confirmed.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 of the reported lot did not indicate a lot specific quality issue.The investigation determined the reported stretched coils appear to be related to the operational context of the procedure.There was no damage or anomalies noted to the guide wire during the inspection prior to use or during preparation for use which suggests a product quality issue did not contribute to the reported difficulties.In this case, it is likely that the guide wire interacted with an accessory device or the patient¿s anatomy during use, resulting in the reported stretched coils and noted bent shaping ribbon.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.H6 - medical device problem code 1562 was removed and replaced with code 1601.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE
• 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: 16553970
• Report Number: 2024168-2023-02740
• Device Sequence Number: 14783846
• Product Code: DQX
• UDI-Device Identifier: 08717648065866
• UDI-Public: 08717648065866
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K101011
• 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
• Report Date (Section B): 05/19/2023

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: 07/31/2024
• Device Model Number: 1009660J
• Device Catalogue Number: 1009660J
• Device Lot Number: 2080971
• 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: 02/23/2023
• Supplement Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2022
• 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 Sex: Unknown