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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LEVEEN SUPERSLIM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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BOSTON SCIENTIFIC CORPORATION LEVEEN SUPERSLIM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Model Number 36705
Medical Device Problem Code Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/04/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that array expansion was poor.A leveen superslip needle electrode was selected for use in a radio frequency ablation procedure to treat liver cancer.During deployment with the needle partly opened, it was noted that array expansion was poor.Another device was used to complete the procedure.No patient complications were reported.
 
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Brand Name
LEVEEN SUPERSLIM
Common Device Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key12100301
Report Number2134265-2021-08380
Device Sequence Number4199435
Product Code GEI
UDI-Device Identifier08714729441694
UDI-Public08714729441694
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K113090
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/01/2021
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
Operator of Device Health Professional
Device Expiration Date09/15/2022
Device Model Number36705
Device Catalogue Number36705
Device Lot Number0024436342
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/07/2021
Initial Report FDA Received Date07/01/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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