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

Model Number 1005357HJ

Device Problem Material Separation (1562)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Hematoma (1884)

Event Date 07/30/2020

Event Type  Injury  

Manufacturer Narrative

The device location was not provided, and it is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.User facility medwatch report number mw 5096430.

Event Description

A user facility medwatch report was received which states, in attempts to declott a left fistula, the physician used a whisper wire; the whisper wire broke off in the fistula; this was removed; the patient then developed a large hematoma and was take to the operating room.No additional information was provided.

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 separation appears to be related to operation circumstances of the procedure.However, based on the reported information by the physician, the reported death is not related to the device or the procedure.It is likely that during the procedure, the guide wire likely became kinked.Manipulation and/or inadvertent mishandling of the guide wire ultimately resulted in the separation.Additionally, the treatment appears to be related to the operational context of the procedure as the separated portion of the guide wire was embedded in the vessel during surgery.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6 patient code 1884 was removed.

Event Description

User facility medwatch report received states that "in attempts to declott a left fistula, the physician used a whisper wire; the whisper wire broke off in the fistula; this was removed; the patient then developed a large hematoma and was take to the operating room.Additional information was received from the account stating the separated portion was embedded in the vessel during surgery and surgery was also performed to treat the hematoma.The physician noted the hematoma was not related to the fracture nor was the death.No additional information was provided.

• Brand Name: HI-TORQUE WHISPER MS GUIDE WIRE
• Type of Device: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10758182
• MDR Text Key: 213871419
• Report Number: 2024168-2020-09046
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08717648037818
• UDI-Public: 08717648037818
• Combination Product (y/n): N
• PMA/PMN Number: K101116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/11/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 1005357HJ
• Device Catalogue Number: 1005357HJ
• Device Lot Number: 0031071
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/07/2020
• Initial Date FDA Received: 10/29/2020
• Supplement Dates Manufacturer Received: 11/20/2020
• Supplement Dates FDA Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention