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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

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ABBOTT VASCULAR EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM Back to Search Results
Model Number 22438-19
Device Problems Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/17/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
 
Event Description
It was reported that this was an atherectomy procedure in the right superficial femoral artery.The physician loaded the nav6 filter on to the non-abbott guide wire.The nav6 was inserted into the patient, but the filter basket detached from the delivery catheter when physician attempted to retrieve it.The emboshield nav6 filter basket came out of the delivery catheter when the physician was removing the barewire from the filter.He was able to retrieve the filter basket with the retrieval device.He used a 2nd nav6 to complete the procedure without further incident.There were no adverse patient effects and no clinically significant delay in the procedure.There was no additional information provided.
 
Manufacturer Narrative
Visual analysis was performed on the returned device and noted a broken filter wire.The improper procedure and separation were unable to be 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 revealed no indication to suggest a lot specific product quality issue.The investigation determined that the reported failure to retrieve the filter was due to the circumstances of the procedure.The incident details stated,¿ the physician loaded the nav6 filter on to the non-abbott guide wire.¿ the barewire has a step that prevents the filter from embolism and enables the filter to be retrieved.The step or bump in the barewire for the emboshield is.019¿.The reported information indicated that the non-abbott wire was a viper 17.The viper 17 wire has a.017¿ step or bump.The filter stop id is.015¿.Additionally, the returned filter was found to have a broken wire.In this case, it is likely that the broken filter wire created enough resistive retrieval force that allowed the.017¿ bump of the viper wire to be pulled through the filter allowing its separation.The break in the filter was due to case circumstance.There is no indication of a product quality issue with respect to the design, manufacture, or labeling.Na.
 
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Brand Name
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
Type of Device
EMBOLIC PROTECTION SYSTEM
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
MDR Report Key11144309
MDR Text Key226093080
Report Number2024168-2021-00276
Device Sequence Number1
Product Code NTE
UDI-Device Identifier08717648137754
UDI-Public08717648137754
Combination Product (y/n)N
PMA/PMN Number
K141678
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/16/2021
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 Expiration Date07/31/2023
Device Model Number22438-19
Device Catalogue Number22438-19
Device Lot Number0081361
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2021
Initial Date Manufacturer Received 12/18/2020
Initial Date FDA Received01/10/2021
Supplement Dates Manufacturer Received02/01/2021
Supplement Dates FDA Received02/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
VIPER 17 GUIDE WIRE
Patient Age59 YR
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