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

Model Number	36700
Medical Device Problem Codes	Retraction Problem (1536); Failure to Unfold or Unwrap (1669); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pneumothorax (2012)
Date of Event	05/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tines were difficult to extend, difficult to retract, and bent.The patient experienced a hemorrhage and a pneumothorax.Leveen coaccess electrode systems were selected for use in a radiofrequency ablation (rfa) procedure to treat a lung tumor.Before use, the device was bench tested on a table, and the coaxial and needle both fitted and deployed without issue.During the procedure, the first coaxial and needle were inserted into the lung, but the needle did not deploy properly.All the tines went in one direction, so they were retracted.The coaxial was twisted, and the tines were deployed again.It still did not deploy circumferentially.The tines were retracted again with difficulty.The physician struggled significantly, so a second needle was selected for use.The first coaxial was left in place, and the same thing happened again.Both times when the probe was removed, the tines were noted to be asymmetrical and skewed.A third needle was selected for use.This time, the first coaxial was removed and replaced with a new one despite the physician acknowledging a risk of a pneumothorax.The third needle was bench tested and then inserted into the lung.The same issues occurred again.The device appeared to be in the correct position, so the tines were deployed.After imaging, it was observed that the needle was not in the correct position, so an attempt was made to close the tines in order to reposition.The tines would not retract at all.A colleague was called for assistance, but the tines could not be retracted.Eventually, with significant force, the tines retracted into the needle sheath.Everything was removed, which was again risking a pneumothorax.The procedure continued using microwave ablation.There was a moderate surrounding hemorrhage and obscuration of the lesion, which made the final procedure difficult, but it was completed successfully.A small pneumothorax was noted post procedure and treated conservatively.The patient was discharged.
Additional Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, one radio frequency probe was returned for analysis.No visual damages or defects were observed on the electrode.The distal section of the two tines were bent; however, during functional evaluation, the device extended and retracted the tines without resistance.Therefore, the reported complaint related to needle/tines bent was confirmed; however, the issues related to needle/tines difficult to extend and needle/tines difficult to retract were not confirmed.
Event or Problem Description
It was reported that the tines were difficult to extend, difficult to retract, and bent.The patient experienced a hemorrhage and a pneumothorax.Leveen coaccess electrode systems were selected for use in a radiofrequency ablation (rfa) procedure to treat a lung tumor.Before use, the device was bench tested on a table, and the coaxial and needle both fitted and deployed without issue.During the procedure, the first coaxial and needle were inserted into the lung, but the needle did not deploy properly.All the tines went in one direction, so they were retracted.The coaxial was twisted, and the tines were deployed again.It still did not deploy circumferentially.The tines were retracted again with difficulty.The physician struggled significantly, so a second needle was selected for use.The first coaxial was left in place, and the same thing happened again.Both times when the probe was removed, the tines were noted to be asymmetrical and skewed.A third needle was selected for use.This time, the first coaxial was removed and replaced with a new one despite the physician acknowledging a risk of a pneumothorax.The third needle was bench tested and then inserted into the lung.The same issues occurred again.The device appeared to be in the correct position, so the tines were deployed.After imaging, it was observed that the needle was not in the correct position, so an attempt was made to close the tines in order to reposition.The tines would not retract at all.A colleague was called for assistance, but the tines could not be retracted.Eventually, with significant force, the tines retracted into the needle sheath.Everything was removed, which was again risking a pneumothorax.The procedure continued using microwave ablation.There was a moderate surrounding hemorrhage and obscuration of the lesion, which made the final procedure difficult, but it was completed successfully.A small pneumothorax was noted post procedure and treated conservatively.The patient was discharged.

• 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: 11956695
• Report Number: 2134265-2021-06814
• Device Sequence Number: 3542965
• Product Code: GEI
• UDI-Device Identifier: 08714729295617
• UDI-Public: 08714729295617
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K140505
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2021

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: 11/30/2023
• Device Model Number: 36700
• Device Catalogue Number: 36700
• Device Lot Number: 0026440402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 07/28/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other