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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR BAREWIRE EMBOSHIELD FILTER DELIVERY WIRE; EMBOLIC PROTECTION SYSTEM Back to Search Results
Catalog Number 22445-31
Device Problems Difficult to Remove (1528); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/06/2022
Event Type  malfunction  
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.The additional emboshield device referenced in b5 is filed under separate medwatch report number.
 
Event Description
It was reported that the procedure was to treat the superficial femoral artery/poplteal artery with heavy calcification and moderate tortuosity.The 315 cm barewire was used with the emboshield nav6 embolic protection system and it was placed in the lower extremity per the instructions for use.The emboshield filter was difficult to advance and remove on the barewire.During use of an atherectomy device, the catheter of the device was getting stuck on the barewire as well as the filter.The devices could only be removed all together as a single unit.Then a drug coated balloon was used to dilate the lesion with a great result.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
 
Manufacturer Narrative
Visual, dimensional, and functional analysis was performed on the returned device.The reported difficulty advancing and difficulty removing was not 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 similar complaints reported from this lot.The investigation was unable to determine a definitive cause for the reported difficulties.It may be possible that the difficulty advancing was the result of challenging anatomical conditions at the location of the peroneal artery.Additionally, the difficulty removing may be the result of the atherectomy device being advanced too close to the filter causing the tip of the atherectomy catheter to become stuck with the proximal end of the filtration element resulting in difficulty removing.However, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
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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 Key16023968
MDR Text Key306828327
Report Number2024168-2022-12937
Device Sequence Number1
Product Code NTE
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K141678
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number22445-31
Device Lot Number2010461
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/06/2022
Initial Date FDA Received12/21/2022
Supplement Dates Manufacturer Received01/26/2023
Supplement Dates FDA Received02/07/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/04/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
EMBOSHIELD NAV6; JETSTREAM ATHERECTOMY DEVICE
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