MAUDE Adverse Event Report: ABBOTT VASCULAR INC. HI-TORQUE WIGGLE; WIRE, GUIDE, CATHETER

Model Number	22299M-W2
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was a transcatheter aortic valve replacement (tavr) with coronary protection in the branch of ramus intermedius artery without calcification.The hi-torque (ht) wiggle guide wire was advanced without resistance, however, the tip broke off inside the anatomy.Per the physician, the cause of fracture was likely contributed by heart beat causing back and forth sheering at the location of a bifurcation when the wire tip was parked in a side branch.Attempts were made to retrieve the tip using a snare device but was unsuccessful.The separated portion was left in the anatomy fixed in the side branch, not free floating, and no filaments hanging out.There was up to an hour of additional procedural time.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.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported material separation was 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 material separation, treatment, and patient effect appear to be related to the operational context of the procedure.In this case, the physician attributed the reported material separation to interaction with the anatomy, they stated the heartbeat likely caused sheering at the location of a bifurcation when the wire tip was parked in a side branch.Additionally, it is likely that interaction with the anatomy also contributed to the noted core and coil damage.The separated portion of the guide wire remains fixed within the anatomy.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Additional Manufacturer Narrative
H2 correction: updated the device identification fields to align with the information in the corresponding fields in gudid.Attachment: user facility medwatch report.

• Brand Name: HI-TORQUE WIGGLE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 17905500
• Report Number: 2024168-2023-11126
• Device Sequence Number: 15362452
• Product Code: DQX
• UDI-Device Identifier: 08717648079719
• UDI-Public: (01)08717648079719(17)240831(10)2092761
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K984394
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2024

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: 08/31/2024
• Device Model Number: 22299M-W2
• Device Catalogue Number: 22299M-W2
• Device Lot Number: 2092761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/20/2023
• Supplement Date Received by Manufacturer: 11/21/2023; 06/13/2024
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 11/30/2023; 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2022
• 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 Age: 56 YR
• Patient Sex: Female