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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 Problems Difficult to Advance (2920); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/14/2022
Event Type  malfunction  
Event Description
It was reported that there was difficulty advancing the isleeve introducer sheath within the artery.Procedure summary: vascular access was obtained via a right transfemoral artery approach.The vasculature was severely tortuous and moderately calcified.A 14f isleeve introducer sheath was inserted; however, the physician felt resistance and the14f isleeve introducer sheath was unable to be advanced within the artery.The 14f isleeve introducer sheath was removed from the patient and tip damage was noted.A new 14f isleeve introducer sheath was prepared and advanced into the patient with no problems.The procedure was successfully completed.Patient status: no patient complications were reported.
 
Manufacturer Narrative
H3 device evaluated by mfr: the returned product consisted of the 14f isleeve introducer sheath with the dilator.The dilator was returned outside of the 14f isleeve introducer sheath.The dilator, cap, sheath, and tip of the 14f isleeve introducer sheath were visually and microscopically examined.Inspection of the 14f isleeve introducer sheath revealed that there were numerous kinks through the 14f isleeve introducer sheath.Two of the three seams were found to be expanded at kinks.The third seam of the 14f isleeve introducer sheath was not expanded; however, the tip of the 14f isleeve introducer sheath was torn at the seam line.The seam expansions are consistent with device use, as designed.The tip damage is consistent with device being used in the patient.The dilator of teh 14f isleeve introducer sheath was able to be inserted and removed from the 14f isleeve introducer sheath with no resistance or issues or further expansion of the seams.Product analysis could not confirm the reported difficulty advancing wtihin the artery, as the clinical circumstances could not be replicated.The reported tip damage and other confirmed damage to the 14f isleeve introducer sheath is consistent to difficulty advancing during the procedure.
 
Event Description
It was reported that there was difficulty advancing the isleeve introducer sheath within the artery.Procedure summary: vascular access was obtained via a right transfemoral artery approach.The vasculature was severely tortuous and moderately calcified.A 14f isleeve introducer sheath was inserted; however, the physician felt resistance and the14f isleeve introducer sheath was unable to be advanced within the artery.The 14f isleeve introducer sheath was removed from the patient and tip damage was noted.A new 14f isleeve introducer sheath was prepared and advanced into the patient with no problems.The procedure was successfully completed.Patient status: no patient complications were reported.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15674890
MDR Text Key306814740
Report Number2124215-2022-43638
Device Sequence Number1
Product Code DYB
UDI-Device Identifier08714729950660
UDI-Public08714729950660
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10445
Device Catalogue Number10445
Device Lot Number0030114050
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/09/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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