MAUDE Adverse Event Report: ABBOTT VASCULAR 014 BMW HYDRO; GUIDE WIRE

Model Number	1001782-HC
Medical Device Problem Codes	Material Separation (1562); Failure to Advance (2524)
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	02/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer reported the device is not returning.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 to treat a calcified lesion in the right coronary artery (rca).The rca was initially wired with a non-abbott guide wire and pre-dilated with an non-abbott balloon.When removing the balloon, the guide wire felt sticky.The guide wire was removed and a bmw guide wire was used.Reportedly, resistance with the anatomy was noted during advancement.The tip of the bmw guide wire broke off.The tip was snared, dragged to the ostium of the vessel and stented over, however; it was unable to be post dilated.Patient did fine.There was no clinically significant delay in the procedure and no adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
The product was not returned to abbott vascular for analysis.Return of the guide wire may have further aided the 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 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 guide wire core separation appears to be related to operational circumstances of the procedure.In this case, based on the reported information, during advancement the guide wire encountered resistance with the anatomy, resulting in the failure to advance and likely causing the tip of the guide wire bend/kink.Further manipulation of the wire against resistance resulted in the tip separation.Additionally, the treatment appears to be related to the operational context of the procedure as the separated tip was snared, dragged to the ostium of the vessel and stented over.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.B2: outcomes attributed to ae - disability/permanent impairment was removed.

• Brand Name: 014 BMW HYDRO
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9928672
• Report Number: 2024168-2020-03392
• Device Sequence Number: 16318968
• Product Code: DQX
• UDI-Device Identifier: 08717648025990
• UDI-Public: 08717648025990
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K021228
• 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): 04/29/2020

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: 09/30/2020
• Device Model Number: 1001782-HC
• Device Catalogue Number: 1001782-HC
• Device Lot Number: 8100571
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 04/29/2020
• 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; Disability