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

Model Number	36700
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	12/17/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a puncture burn occurred.The patient was undergoing a radiofrequency ablation (rfa) procedure in their lung.A 3.0/15/15 leveen coaccess was used.Access was gained using a posterior approach on the right apical nodule and a 100w cycle was done for 1 minute.The needle was "entered using a forceps" in order to avoid thermal lesions of the anterior pleura.It was reported there was a possible crack in the leveen coaccess.The patient sustain a third degree burn that appeared while "warmin on accross tha area in contact with the metallic forceps." the procedure was interrupted.The burn was treated with a cold wet compress (jelonet and lumazine).The patient was referred to the surgical center for repair.Controlled wound healing started the following day.
Event or Problem Description
It was reported that a puncture burn occurred.The patient was undergoing a radiofrequency ablation (rfa) procedure in their lung.A 3.0/15/15 leveen coaccess was used.Access was gained using a posterior approach on the right apical nodule and a 100w cycle was done for 1 minute.The needle was "entered using a forceps" in order to avoid thermal lesions of the anterior pleura.It was reported there was a possible crack in the leveen coaccess.The patient sustain a third degree burn that appeared while "warmin on accross tha area in contact with the metallic forceps." the procedure was interrupted.The burn was treated with a cold wet compress (jelonet and flammazine).The patient was referred to the surgical center for repair.Controlled wound healing started the following day.It was further reported that the physician held the needle with a metallic forceps.The electrical conduction caused the burn.The patient returned home without further intervention.

• Brand Name: LEVEEN COACCESS
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9604903
• Report Number: 2134265-2020-00253
• Device Sequence Number: 2677000
• Product Code: GEI
• UDI-Device Identifier: 08714729454922
• UDI-Public: 08714729454922
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140504
• 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,Followup
• Report Date (Section B): 02/10/2020

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: 08/19/2022
• Device Model Number: 36700
• Device Catalogue Number: 36700
• Device Lot Number: 0024296011
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/23/2019
• Supplement Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 01/19/2020
• Supplement Report FDA Received Date: 02/10/2020
• 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: Required Intervention