MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE WHISPER ES GUIDE WIRE

Model Number	1011834H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Embolism (1829)
Date of Event	09/29/2020
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 this was a procedure to place a biventricular lead insertion.The whisper guide wire was advanced without resistance into the right atrium and it was noted that the guide wire tip became knotted and broke off.The separated tip traveled and embolized in the left ventricle.A snare device was used to successfully retrieve the separated guide wire tip.No additional information was provided.
Additional Manufacturer Narrative
The device was returned.Visual and dimensional analysis was performed on the returned device.The core 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.Based on the information provided, the investigation determined that the reported separation appears to be due to case circumstances.It is likely that the separation was a result of the wire becoming knotted and damaged due to the anatomical conditions.Additionally, the additional treatment, embolism and removal of device are related to the circumstances of the procedure.The reported patient effect of embolism is listed in the hi-torque guide wires instruction for use as a known potential adverse event associated with the use of this device.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: HI-TORQUE WHISPER ES GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10707603
• Report Number: 2024168-2020-08745
• Device Sequence Number: 11655057
• Product Code: DQX
• UDI-Device Identifier: 08717648116100
• UDI-Public: 08717648116100
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K101116
• 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): 11/17/2020

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: 09/30/2021
• Device Model Number: 1011834H
• Device Catalogue Number: 1011834H
• Device Lot Number: 9100271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 11/17/2020
• 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