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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ISLEEVE 15F; INTRODUCER, CATHETER
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BOSTON SCIENTIFIC CORPORATION ISLEEVE 15F; INTRODUCER, CATHETER Back to Search Results
Model Number 10445
Device Problems Failure to Advance (2524); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Stenosis (2263)
Event Date 03/11/2020
Event Type  Injury  
Event Description
It was reported that left femoral artery occlusion occurred.Vascular access was obtained via the left femoral artery.A 15f isleeve introducer sheath was inserted and resistance was felt when advancing a lotus edge valve system through the isleeve.A left femoral artery occlusion occurred after sheath removal.The occlusion was opened with a stent and blood flow was restored.The patient status is fine.
 
Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of an isleeve introducer sheath with the dilator inside the sheath.The device was bloody.Analysis of the tip, sheath, and hub/valve included microscopic and visual inspection.Inspection revealed numerous kinks in the sheath and tip damage (torn).The seams of the device were opened, consistent with device used.Functional testing could not be performed due to the excessive sheath damage (kinking).Procedural imaging was provided to assist in the investigation and was reviewed by a boston scientific quality engineer.A single, 25-second-long movie file was provided for review.The file shows the withdrawal of the lotus edge device through the isleeve without issue post valve release.The complaint event of difficulty advancing the lotus edge device into the introducer sheath cannot be confirmed from this file.
 
Event Description
It was reported that left femoral artery occlusion occurred.Vascular access was obtained via the left femoral artery.A 15f isleeve introducer sheath was inserted and resistance was felt when advancing a lotus edge valve system through the isleeve.A left femoral artery occlusion occurred after sheath removal.The occlusion was opened with a stent and blood flow was restored.The patient status is fine.
 
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Brand Name
ISLEEVE 15F
Type of Device
INTRODUCER, CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9883884
MDR Text Key185920564
Report Number2134265-2020-03620
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 04/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number10445
Device Catalogue Number10445
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/03/2020
Date Manufacturer Received04/16/2020
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age82 YR
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