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

Catalog Number	1000462H
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported the procedure was in the subclavian vein with no stenosis or tortuosity.The hi-torque 014 bhw hydro 190cm guide wire and the ht powerturn 190cm guide wire could not be seen during procedure.The radiopacity tip mark of both guide wires could not be visualized.Another ht bhw guide wire was used in the procedure.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.
Additional Manufacturer Narrative
H6: medical device problem code 1494 - incorrect anatomy manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The ht powerturn guide wire referenced in b5 is filed under a separate medwatch report number.
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 was unable to determine a conclusive cause for the reported poor visibility of tip marker.Factors that may contribute to poor visibility of tip marker include, but are not limited to, coil size, coil material properties, solder length, solder material, interaction accessory devices, imaging technique, or damage to the guide wire.Based on the information provided and because the device was not returned for analysis, it is unknown what may have caused the reported poor visibility of tip marker.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6: medical device problem code 1494 was removed.

• 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: 17574712
• Report Number: 2024168-2023-08973
• Device Sequence Number: 9006375
• Product Code: DQX
• UDI-Device Identifier: 08717648015489
• UDI-Public: 08717648015489
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• 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
• Report Date (Section B): 10/31/2023

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: 03/31/2025
• Device Catalogue Number: 1000462H
• Device Lot Number: 3040571
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 08/18/2023
• Supplement Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GE INTERNATIONAL MACHINE
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 57 KG