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

Model Number	1005357HJ
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional whisper guide wire referenced is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was performed to treat a heavily calcified lesion in the left circumflex artery.A 014 whisper guide wire was used; however, during removal resistance with the anatomy was felt and the tip separated.A snare was used to remove the separated portion from the patient.A second 014 whisper guide wire was used, but it was observed that it had almost sheared.Due to the issue with the first two guide wires, the third selected 014 whisper guide wire was not used.There was a 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 separation was confirmed.The reported failure to advance was unable to be replicated in a testing environment as it was based on operational circumstances.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 difficulty to remove and tip separation appear to be related to operational circumstances of the procedure.In this case it is likely that the guide wire interacted with the heavily calcified anatomy causing the difficulty to remove.Manipulation against resistance likely caused the guide wire to kink ultimately resulting in the core and polymer separation.Additionally, the reported treatments appear to be related to the operational context of the procedure as the separated section of the guide wire was removed using a snare device.There is no indication of a product quality issue with respect to manufacture, design, or labeling.An additional unused, sterile guide wire from the same part/lot as complaint device was returned.The guide wire was visually inspected with no anomalies noted.

• Brand Name: HI-TORQUE WHISPER MS GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11962411
• Report Number: 2024168-2021-04790
• Device Sequence Number: 16937204
• Product Code: DQX
• UDI-Device Identifier: 08717648037818
• UDI-Public: 08717648037818
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K101116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021

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: 11/30/2022
• Device Model Number: 1005357HJ
• Device Catalogue Number: 1005357HJ
• Device Lot Number: 0120771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 07/21/2021
• 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: 70 YR
• Patient Weight: 82