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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT RX HERCULINK ELITE STENT SYSTEM
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AV-TEMECULA-CT RX HERCULINK ELITE STENT SYSTEM Back to Search Results
Catalog Number 1011493-18
Device Problems Difficult to Remove (1528); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/03/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The hi-torque device is being filed under a separate medwatch report.
 
Event Description
It was reported that the procedure was performed to treat a lesion with moderate calcification in the right renal artery.During advancement, the ht spartacore guide wire met resistance and got stuck with the herculink elite balloon catheter.Angiography showed that the guide wire tip had separated inside the herculink balloon catheter.Both devices were pulled back into the sheath and were all removed as one complete unit.A new spartacore guide wire and new herculink balloon catheter were used to complete the procedure successfully.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
 
Manufacturer Narrative
Internal file number - (b)(4).The incident information was reviewed; however, 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 from this lot.The investigation determined the reported/noted difficulty to position, to remove appear to be related to circumstances of the procedure.It is likely inadvertent mishandling of the device during preparation or during loading of the wire the distal shaft of the device became kinked resulting in the reported difficulty to position the wire.Additional manipulation of the wire and device likely caused the wire to separate causing the reported difficulty to remove.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
 
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Brand Name
RX HERCULINK ELITE STENT SYSTEM
Type of Device
STENT SYSTEM
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
MDR Report Key8267719
MDR Text Key133763760
Report Number2024168-2019-00486
Device Sequence Number1
Product Code NIN
Combination Product (y/n)N
PMA/PMN Number
P110001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Remedial Action Other
Type of Report Initial,Followup
Report Date 02/11/2019
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 Date10/31/2021
Device Catalogue Number1011493-18
Device Lot Number8110861
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/04/2019
Initial Date FDA Received01/22/2019
Supplement Dates Manufacturer Received02/02/2019
Supplement Dates FDA Received02/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SPARTACORE GUIDE WIRE; SPARTACORE GUIDE WIRE
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