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

Model Number	1005359H
Medical Device Problem Codes	Material Separation (1562); Failure to Advance (2524)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a heavily calcified and occluded lesion in the anterior tibial (at) artery.A 014 ht whisper guide wire was being advanced to the lesion through a crossing catheter; however, it failed to cross due to resistance with the anatomy.The guide wire was removed and it was noted that the tip had separated.The physician believes he was in a collateral vessel when the guide wire was removed and the tip remained in the patient.No attempt was made to remove the separated tip as it is not free-floating, and it remains in the at artery or collateral.The procedure was completed.There was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual and dimensional inspections were 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 difficulties appears to be related to operational circumstances of the procedure.Based on the reported information, it is likely that the device interacted with the challenging anatomy during advancement resulting in the reported failure to advance.It is likely that the tip kinked against the anatomy resulting in the tip separation and noted polymer tear during retraction.There is no indication of a product quality issue with respect to manufacture, design or labeling.D4: lot number d4: expiration date.H4: device mfg date.

• 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: 10186927
• Report Number: 2024168-2020-05282
• Device Sequence Number: 835753
• Product Code: DQX
• UDI-Device Identifier: 08717648037825
• UDI-Public: 08717648037825
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 08/12/2020

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: 06/30/2021
• Device Model Number: 1005359H
• Device Catalogue Number: 1005359H
• Device Lot Number: 9072471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 06/23/2020
• Supplement Report FDA Received Date: 08/12/2020
• 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: 76 YR