MAUDE Adverse Event Report: ABBOTT VASCULAR ACS HI-TORQUE WIGGLE GUIDE WIRE

Model Number	22299M-W2
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	10/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the right coronary artery.An unspecified balloon catheter was used with a wiggle guide wire with no resistance noted.During removal without resistance, the tip of the guide wire separated, so an unspecified stent was used to embed the separated portion.The patient was fine.There were no adverse patient sequelae and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned guide wire and the reported tip 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 and or complaints reported from this lot.There was no damage noted to the guide wire during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.The investigation determined the reported tip separation appears to be related to operational circumstances of the procedure.It is likely that during the procedure, the guide wire tip kinked against the anatomy and/or other devices used.Manipulation of the guide wire during retraction likely resulted in the reported/noted separations.Additionally, the reported treatment appears to be related to the operational context of the procedure as an unspecified stent was used to embed the separated portion of the wire to the vessel or plaque.The noted bends on the wire likely occurred during packing for return analysis.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: ACS HI-TORQUE WIGGLE GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10773339
• Report Number: 2024168-2020-09125
• Device Sequence Number: 16563958
• Product Code: DQX
• UDI-Device Identifier: 08717648079719
• UDI-Public: 08717648079719
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K984394
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2020

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: 11/30/2020
• Device Model Number: 22299M-W2
• Device Catalogue Number: 22299M-W2
• Device Lot Number: 8120461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 12/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR