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

Model Number 36705

Device Problems Device Displays Incorrect Message (2591); Material Twisted/Bent (2981)

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

Event Date 11/27/2023

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter address 1: (b)(6).

Event Description

It was reported that the needle kinked.A 2.0/17/15 leveen superslim was selected for use to treat liver cancer.During the procedure, the device frequently reported an alert and stopped working.It was found that the needle was kinked after it was withdrawn.The procedure was completed with another of the same device.There were no patient complications reported.

Manufacturer Narrative

E1: initial reporter address 1: (b)(6).Device evaluated by mfr: the electrode device was returned, and no damages were observed at the handle.Visual inspection revealed that the needles were bent.Functional inspection was performed by extending and retracting the handle, and the needle/tines were activated without any problems.An electrical evaluation was performed by measuring the continuity, the electrode was able to conduct current indicating proper connectivity.The resistance test was within specification.

Event Description

It was reported that the needle kinked.A 2.0/17/15 leveen superslim was selected for use to treat liver cancer.During the procedure, the device frequently reported an alert and stopped working.It was found that the needle was kinked after it was withdrawn.The procedure was completed with another of the same device.There were no patient complications reported.

• 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: 18335272
• MDR Text Key: 331000823
• Report Number: 2124215-2023-71204
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K113090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• 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: 0028700979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2022
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 69 KG