MAUDE Adverse Event Report: ABBOTT VASCULAR BAREWIRE EMBOSHIELD FILTER DELIVERY WIRE; EMBOLIC PROTECTION SYSTEM

Model Number 22440-31

Device Problems Difficult to Remove (1528); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/08/2022

Event Type  Injury  

Event Description

It was reported that the procedure was performed to treat a lesion in the mildly calcified distal right peroneal artery.The barewire guide wire was used with a filter and no difficulties were noted.The barewire then recrossed to the target lesion and a non-abbott exchange catheter was advanced.The barewire was then retrieved; however, there was interaction with the non-abbott device and the tip of the barewire separated.A snare device was used to retrieve the separated tip without any patient effect.There was no adverse patient effect or clinically significant delay.No additional information was provided.

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported separation was confirmed.The reported difficulty removing was unable to be tested due to the condition of the returned unit.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 complaints reported from this lot.The investigation determined that the reported difficulty removing, material separation and additional unexpected medical intervention to snare the separated tip were due to circumstances of the procedure.It is likely that interaction with the non-abbott exchange catheter caused the reported resistance during removal and ultimately caused the tip of the barewire to stretch and separate and noted on the returned unit.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Manufacturer Narrative

The other barewire guide wire referenced in b5 is filed under a separate medwatch report number: 2024168-2023-00397.

Event Description

Subsequent to the initial report, the barewire guide wire was received entwined with another separated barewire guide wire tip.The site has no recollection of the second separated barewire, and therefore, was unable to provide any additional information.There was no report of an adverse patient effect due to the second separated barewire and no report of a clinically significant delay in procedure.No additional information was provided.

• Brand Name: BAREWIRE EMBOSHIELD FILTER DELIVERY WIRE
• Type of Device: EMBOLIC PROTECTION SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 15894934
• MDR Text Key: 304616226
• Report Number: 2024168-2022-12076
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 08717648137808
• UDI-Public: 08717648137808
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22440-31
• Device Catalogue Number: 22440-31
• Device Lot Number: 2062763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TERUMO NAVICROSS EXCHANGE CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female