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

Model Number 36705

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/14/2023

Event Type  malfunction  

Event Description

It was reported that the needle was deformed.The target lesion was located in the right inferior lung.A 3.0/17/15 leveen superslim was selected for use.During the procedure, after local anesthesia, the device was found to be deformed and curved when taken out of the patient.A new ablation needle was used to complete the procedure.There were no patient complications, and the patient was stable post procedure.

Manufacturer Narrative

Initial reporter address 1: (b)(6).

Event Description

It was reported that the needle was deformed.The target lesion was located in the right inferior lung.A 3.0/17/15 leveen superslim was selected for use.During the procedure, after local anesthesia, the device was found to be deformed and curved when taken out of the patient.A new ablation needle was used to complete the procedure.There were no patient complications, and the patient was stable post procedure.

Manufacturer Narrative

E1: initial reporter address 1: (b)(6).Device evaluated by mfr: the electrode device was returned with the rfa electrode cable; nevertheless, media was provided, and it was observed that the device was bent.Visual inspection revealed no damages at the handle device and it was observed that the needle was bent.Functional inspection was performed by extending and retracting the handle, and the needle/tines were activated without any problems.

• Brand Name: LEVEEN SUPERSLIM
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18380473
• MDR Text Key: 331361344
• Report Number: 2124215-2023-72492
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 08714729441717
• UDI-Public: 08714729441717
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K113092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/01/2024

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
• Device Operator: Health Professional
• Device Model Number: 36705
• Device Catalogue Number: 36705
• Device Lot Number: 0032074667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 02/06/2024
• Supplement Dates FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 60 KG