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

Catalog Number	1000462H
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Stretched (1601); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2023
Type of Reportable Event	Serious Injury
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 the procedure was to treat a heavily calcified lesion in the left anterior descending (lad) coronary artery.The tip of the balance heavyweight (bhw) guide wire met resistance with the anatomy during advancement and during removal the end of the wire was stuck and began to unravel as it was pulled back.A non-abbott catheter was placed over the guide wire with the support of a runthrough guide wire and advanced distally to allow the bhw guide wire to be slowly removed with the catheter.There were no adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.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 determined the reported difficulties and subsequent treatment appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.D9, h3: updated return status of device to no.
Additional Manufacturer Narrative
A visual and dimensional analysis was performed on the returned device.The reported difficult to advance and difficult to remove could not be tested due to the device condition.The reported break and 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 identified no other incidents/complaints from this lot.The investigation determined the reported difficulties and subsequent treatment appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.D9, h3: updated return status of device to yes.H6: type of investigation code 4115 removed; 10 added; investigation findings code 3221 removed; 114 added; investigation conclusions code 4315 removed; 4311 added.

• Brand Name: HI-TORQUE BALANCE HEAVYWEIGHT 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: 18096888
• Report Number: 2024168-2023-12438
• Device Sequence Number: 17570212
• Product Code: DQX
• UDI-Device Identifier: 08717648015489
• UDI-Public: 08717648015489
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2024

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: 11/30/2024
• Device Catalogue Number: 1000462H
• Device Lot Number: 2122971
• 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: 10/19/2023
• Supplement Date Received by Manufacturer: 12/04/2023; 01/22/2024
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 12/22/2023; 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/29/2022
• 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