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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ISLEEVE 14F; INTRODUCER, CATHETER
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BOSTON SCIENTIFIC CORPORATION ISLEEVE 14F; INTRODUCER, CATHETER Back to Search Results
Model Number 10445
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 03/31/2021
Event Type  malfunction  
Event Description
It was reported that a partial tip detachment occurred and left inside the patient.Vascular access was obtained via a transfemoral approach.A 14f isleeve introducer sheath was positioned.An unspecified manufacturer's valve was successfully implanted to treat the native aortic valve.At the end of the procedure, the 14f isleeve introducer sheath was removed from the patient and a part of the tip was noticed to be missing.Angiographic images revealed the detached tip fragment was inside the patient in an extra vascular location.The physician attempted to retrieve the device fragment using artery forceps.The retrieval attempt was unsuccessful.The physician decided to leave the piece in the patient.No patient complications were reported.
 
Event Description
It was reported that a partial tip detachment occurred and left inside the patient.Vascular access was obtained via a transfemoral approach.A 14f isleeve introducer sheath was positioned.An unspecified manufacturer's valve was successfully implanted to treat the native aortic valve.At the end of the procedure, the 14f isleeve introducer sheath was removed from the patient and a part of the tip was noticed to be missing.Angiographic images revealed the detached tip fragment was inside the patient in an extra vascular location.The physician attempted to retrieve the device fragment using artery forceps.The retrieval attempt was unsuccessful.The physician decided to leave the piece in the patient.No patient complications were reported.It was further reported that the valve system used in the event was an acurate neo2 valve system.The 14f isleeve device fragment extra vascular location was below the insertion point in the right femoral artery.
 
Manufacturer Narrative
B5 describe event or problem - updated h3 device evaluated by mfr: returned device consisted of an isleeve sheath with the dilator in the sheath.Photographic images and fluoroscopic videos were provided to aid in the investigation.The returned device, photographic images and fluoroscopic videos were reviewed by a boston scientific quality engineer.Analysis of the photographs, video, isleeve tip, isleeve sheath and isleeve hub/valve included microscopic and visual inspection.Inspection revealed kinks in the isleeve sheath located 12.5cm, 14cm, and 1635cm from the tip of the device, 2 of the 3 seams were opened (one of the seams fully opened), and the tip was missing a small portion of material next to the opened seam area.In the fluoroscopic videos, the object seen is consistent with the missing material observed on the returned device.Inspection of the rest of the device found no other damage or defects.The reported unretrieved tip detachment in the anatomy was confirmed.
 
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Brand Name
ISLEEVE 14F
Type of Device
INTRODUCER, CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11697868
MDR Text Key246484352
Report Number2134265-2021-04343
Device Sequence Number1
Product Code DYB
UDI-Device Identifier08714729950660
UDI-Public08714729950660
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/16/2021
Device Model Number10445
Device Catalogue Number10445
Device Lot Number0024943717
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/20/2021
Date Manufacturer Received05/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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