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

Device Problem Defective Device (2588)

Patient Problems Muscle Weakness (1967); Necrosis (1971); Numbness (2415); Full thickness (Third Degree) Burn (2696); Skin Infection (4544)

Event Date 10/27/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the patient experienced burns.A leveen superslim probe was selected for radiofrequency ablation of an osteoblastoma of the lower sacrum.The probe used to conduct the radio frequency ablation was defective.The patient experienced electrical burns affecting the soft tissue in the buttock along the insertion tract of the needle and the surrounding nerves requiring surgical treatment for wound debridement and secondary closure.The patient developed an infection requiring treatment with antibiotics.A large area of necrosis developed which subsequently required surgical debridement of the back and right buttock.Further surgical treatment was performed by a plastic surgery team.The patient has a severe level of disability including numbness and weakness in the lower limbs and back.

• Brand Name: LEVEEN STANDARD
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14116395
• MDR Text Key: 289313346
• Report Number: 2134265-2022-03748
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: 505
• Type of Report: Initial
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Disability