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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INNOVA VASCULAR; STENT, SUPERFICIAL FEMORAL ARTERY
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BOSTON SCIENTIFIC CORPORATION INNOVA VASCULAR; STENT, SUPERFICIAL FEMORAL ARTERY Back to Search Results
Model Number 26926
Device Problem Entrapment of Device (1212)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/14/2019
Event Type  malfunction  
Event Description
It was reported that the device became stuck on the guidewire.An innova 6x150x130 self expanding stent was selected to be implanted in the superficial femoral artery (sfa).After the stent was successfully deployed, the catheter became stuck on the wire upon retrieval.The deployment system and wire were successfully removed from the patient.There were no patient complications and the patient is fine.
 
Manufacturer Narrative
Device analysis by mfr: the returned product consisted of an innova self-expanding stent system with an unknown 0.035" guidewire inside the device.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the pull rack is bent.There is a kink to the outer sheath at the nosecone.Microscopic examination revealed no additional damages.The wire was unable to be removed initially so it was x-rayed to see if there were any damages in the handle.No additional damages were seen so the device was placed in a water bath.After soaking, the wire was able to be removed.Inspection of the remainder of the device presented no other damage or irregularities.
 
Event Description
It was reported that the device became stuck on the guidewire.An innova 6x150x130 self expanding stent was selected to be implanted in the superficial femoral artery (sfa).After the stent was successfully deployed, the catheter became stuck on the wire upon retrieval.The deployment system and wire were successfully removed from the patient.There were no patient complications and the patient is fine.
 
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Brand Name
INNOVA VASCULAR
Type of Device
STENT, SUPERFICIAL FEMORAL ARTERY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8846235
MDR Text Key152802345
Report Number2134265-2019-08973
Device Sequence Number1
Product Code NIP
UDI-Device Identifier08714729874041
UDI-Public08714729874041
Combination Product (y/n)N
PMA/PMN Number
P140028
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/20/2019
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 Date06/10/2022
Device Model Number26926
Device Catalogue Number26926
Device Lot Number0023930913
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/05/2019
Initial Date Manufacturer Received 07/15/2019
Initial Date FDA Received07/31/2019
Supplement Dates Manufacturer Received08/14/2019
Supplement Dates FDA Received08/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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