MAUDE Adverse Event Report: ABBOTT VASCULAR HT WIGGLE GUIDE WIRE WITH MICROGLIDE COATING

Model Number	22299M-W2
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product 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 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.In this case, it is likely that during advancement through the anatomy and/or other devise used, the tip became kinked or bent.Manipulation of the guide wire during the procedure likely resulted in the tip separation.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was performed to treat a target lesion in the distal obtuse marginal artery.The wiggle guide wire was used and during the procedure, the tip of the wiggle wire broke off in the patient anatomy.The separated tip could not be removed and remains in the patient anatomy.No additional information was provided.

• Brand Name: HT 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: 9907282
• Report Number: 2024168-2020-03156
• Device Sequence Number: 16823832
• Product Code: DQX
• UDI-Device Identifier: 08717648079719
• UDI-Public: 08717648079719
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 03/31/2020

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: 11/30/2021
• Device Model Number: 22299M-W2
• Device Catalogue Number: 22299M-W2
• Device Lot Number: 9120262
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 03/31/2020
• 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: Other
• Patient Age: 65 YR
• Patient Weight: 104