MAUDE Adverse Event Report: ABBOTT VASCULAR WIGGLE WIRE MICRO; GUIDE WIRE

Model Number	22299M-W2
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to abbott vascular 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 to be case circumstances.It is likely that the guide wire encountered difficulties with the challenging anatomy and as such was difficult to advance and resulted in a broken tip.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.Na.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the left anterior descending (lad) coronary artery.A 014 wiggle guide wire was advancing to the lesion; however, the guide wire could not cross to the target lesion due to anatomy.After removing the guide wire, it was observed that the tip was broken.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: WIGGLE WIRE MICRO
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10393758
• Report Number: 2024168-2020-06700
• Device Sequence Number: 19568701
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/11/2020

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: 08/31/2020
• Device Model Number: 22299M-W2
• Device Catalogue Number: 22299M-W2
• Device Lot Number: 8090461
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 08/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1