MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LEVEEN STANDARD; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	36719
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	11/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: the date of event is unknown.Bsc became aware of the event on 06-nov-2020.Therefore, a date of (b)(6) 2020 was entered to indicate that the event occurred on an unknown day in (b)(6) 2020.
Event or Problem Description
It was reported a hematoma occurred.A radiofrequency ablation procedure was being performed.On renal tumor.A 3.5cm leveen standard electrode was used with an rf3000 generator to ablate the tissue.When the electrode was deployed, the tines were bunched up and not properly extended.This occurred several times, so the electrode was removed and tested outside the patient.The electrode seemed to work fine.A new electrode was then selected and used to complete the ablation.This led to a prolonged procedure time.During the procedure at an unknown time, the patient complained of pain.A scan was performed which noted the patient had complication of bleed with subcapsular hematoma.The patient was admitted overnight for observation and two additional ct scans were performed.Medication was administered to reduce the bleeding.The bleeding stopped and the patient was discharged.

• Brand Name: LEVEEN STANDARD
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10906214
• Report Number: 2134265-2020-16339
• Device Sequence Number: 3217548
• Product Code: GEI
• UDI-Device Identifier: 08714729300618
• UDI-Public: 08714729300618
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K140496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/09/2022
• Device Model Number: 36719
• Device Catalogue Number: 36719
• Device Lot Number: 0024576612
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention