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

Catalog Number	1000462HJ
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the hi-torque balance heavyweight hydro guide wire broke in two, in the stent.The 3.5x48mm xience skypoint stent separated and a stent fracture was noted at the ostium of the right coronary artery.Another stent was use to embed the separated portion of the stent; however, it is unknown if the separated portion of the guide wire was removed.There was no clinically significant delay reported.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional xience skypoint device referenced in b5 is filed under separate medwatch report number.
Event or Problem Description
Subsequently, it was noted that that no piece of the guide wire left in the anatomy and per device return it was noted that the entire length of the guide wire was returned; however, separated from the distal core and shaping ribbon from the solder tip.There was no adverse patient effects reported.No additional information was provided.
Additional Manufacturer Narrative
H6: health effect - clinical code 2687 removed, 4582 added.H6: health effect - impact code 4614 removed, 2199 added.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported material separation was confirmed.A review of the corrective and preventive actions (capa) database was performed and revealed no related complaint assessment capas.The lot history record (lhr) 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.The investigation was unable to determine a conclusive cause for the reported material separation.In this case, it was reported that the guide wire separated within the anatomy.Factors that may contribute to material separation during use include, but are not limited to, interaction with challenging anatomy, interaction with accessory devices, excessive force, manipulation against resistance, or inadvertent damage to the guide wire.Analysis of the returned device noted the coils were stretched distally, indicating the wire was manipulation against resistance.It is possible that post stent deployment, during guide wire removal, the guide wire interacted with the implanted stent, resulting in the reported material separation; 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 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: 18862434
• Report Number: 2024168-2024-02981
• Device Sequence Number: 14287511
• Product Code: DQX
• UDI-Device Identifier: 08717648015496
• UDI-Public: (01)08717648015496(17)250131(10)3021771
• 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,Followup
• Report Date (Section B): 04/25/2024

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: 01/31/2025
• Device Catalogue Number: 1000462HJ
• Device Lot Number: 3021771
• 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: Not provided
• Supplement Date Received by Manufacturer: 03/20/2024; 04/08/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 04/04/2024; 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2023
• 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: 3.5X48MM XIENCE SKYPOINT.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown