MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE WIGGLE GUIDE WIRE WITH MICROGLIDE COATING

Model Number	22299M-W2
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2021
Type of Reportable Event	Serious Injury
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 similar incidents reported from this lot.The investigation determined that anatomical conditions likely caused the difficulties to extract the guidewire during the procedure.It is likely that based on the reported information, the ht wiggle guide wire became stuck with the lesion due to the heavy tortuosity, and 90% stenosis in the left atrioventricular artery.As such, the additional intervention of a balloon allowed the wire to be removed with no damage to the stent.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was performed to treat a de novo lesion with mild calcification, heavy tortuosity, and 90% stenosis in the left atrioventricular artery.A 2.5 x 23 mm xience skypoint stent was implanted and no issues were noted during the removal of the stent delivery system.The ht wiggle guide wire became stuck with the lesion during the removal.The guide wire was removed by delivering a balloon and the procedure was completed with a non-abbott guide wire.There was no damage noted with the stent after the guide wire was removed.There was no adverse patient effect.There was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: HI-TORQUE WIGGLE 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: 11334466
• Report Number: 2024168-2021-01235
• Device Sequence Number: 11021579
• Product Code: DQX
• UDI-Device Identifier: 08717648079719
• UDI-Public: 08717648079719
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/16/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 22299M-W2
• Device Catalogue Number: 22299M-W2
• Device Lot Number: 0011061
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 02/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STENT: XIENCE SKYPOINT 2.5 X 23
• Outcome Attributed to Adverse Event: Required Intervention