MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE FLOPPY II EXTRA SUPPORT GUIDE WIRE WITH MICROGLIDE COATING

Model Number	22299M
Medical Device Problem Codes	Break (1069); Stretched (1601)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that during a complex heavily calcified mid-right coronary artery intervention after the lesion was stented, additional lesions were noted distal to the stent.A hi torque floppy ii extra support guide wire (gw) was advanced distally and a balloon catheter was advanced over the wire to dilate the distal lesion.After removal of the gw through the bleedback valve, the gw appeared to have sheared/unraveled from the proximal part to the soft tip of the wire.All devices were removed at that time.Nothing was left in the patient.There was no adverse patient effect or a clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The break and stretched wire was confirmed.Additionally, the wire was noted to be twisted and scratched.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.The investigation was unable to determine a cause for the reported stretched coil, and break events.It may be possible that during insertion of the wire into the complex heavily calcified vessel, the coils were damaged leading to break and stretch; however, this could not be confirmed.The additional noted twisted and scratched material in the returned analysis were likely due to the circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.

• Brand Name: HI-TORQUE FLOPPY II EXTRA SUPPORT GUIDE WIRE WITH MICROGLIDE COATING
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11402576
• Report Number: 2024168-2021-01655
• Device Sequence Number: 17051773
• Product Code: DQX
• UDI-Device Identifier: 08717648079696
• UDI-Public: 08717648079696
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K913353
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2021

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: 09/30/2021
• Device Model Number: 22299M
• Device Catalogue Number: 22299M
• Device Lot Number: 9100761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1