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

Catalog Number	1001780J-HC
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Device Damaged by Another Device (2915); Difficult to Advance (2920)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure in the diagonal coronary artery with medium calcification and no tortuosity, an unspecified stent was implanted in the left anterior descending (lad) artery, followed by post-dilation.Noting resistance during advancement with the anatomy and the guiding catheter, the 190cm ht torque balance middleweight guide wire (gw) was switched with an unspecified gw between the diagonal coronary artery and the lad coronary artery in order to open the stent struts towards the diagonal artery.Upon withdrawal of the gw, resistance was felt with the diagonal artery and the stent.The gw tip separated.Unspecified attempts were made to retrieve the tip; however, retrieval was unsuccessful and the separated segment remains between the implanted stent and the lad wall.The procedure was prolonged, with the patient receiving increased doses of x-ray and iodinated contrast material.The hospitalization was prolonged, as additional monitoring was required due to the thromboembolic risk.There was no adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
H6: 2017 device code clarifier- failure to follow steps / instructions.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the corrective and preventive actions (capa) database was performed and revealed no related complaint assessment capas.The electronic lot history record (elhr) no associated manufacturing nonconformities issued to the reported lot.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.It was reported that the stent was implanted such that the guide wire became stuck between the stent and vessel wall.It should be noted that the hi-torque balance guide wire instructions for use states: ¿torque a guide wire if the tip becomes entrapped within the vasculature.¿ the investigation determined the reported difficulty during advancement, patient effect, and treatment appear to be related to the operational context of the procedure.Additionally, it is likely that the reported difficulty during removal, material separation, device damaged by another service, and patient effects were due to a use deviation.In this case, it was reported that the guide wire interacted with the patient¿s moderately calcified lesion during advancement, resulting in the reported difficulty during advancement.Additionally, it was reported that the stent was implanted such that the guide wire became stuck between the stent and the vessel wall.It is possible that manipulation of the guide wire, after becoming stuck, resulted in the reported material separation.Damage to the guide wire would have impacted its maneuverability, possibly resulting in the reported difficulty during removal from the guide catheter.The separated portion of the guide wire remains between the implanted stent and the vessel wall.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 18879782
• Report Number: 2024168-2024-03143
• Device Sequence Number: 7820815
• Product Code: DQX
• UDI-Device Identifier: 08717648025983
• UDI-Public: (01)08717648025983(17)250930(10)3100571
• 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
• Report Date (Section B): 04/23/2024

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: 09/30/2025
• Device Catalogue Number: 1001780J-HC
• Device Lot Number: 3100571
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/20/2024
• Supplement Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/05/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown