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

Model Number	36700
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.
Event or Problem Description
It was reported a detachment occurred.The patient was undergoing a pulmonary radio frequency ablation procedure on an unknown date.During removal of the probe, the distal portion (1 cm long) remained stuck to the patient's lung.The procedure was stopped and surgery was performed to remove the detached portion of the probe.No further patient complications were reported.
Additional Manufacturer Narrative
Adverse event/product problem: corrected from adverse event/product problem to product problem.Outcomes attrib to adv event corrected from required intervention to prevent permanent impairment/damage to not applicable.Describe event or problem: corrected.Type of reportable event corrected from serious injury to malfunction.(b)(4).The exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.Device eval by manufacturer: an examination of the device revealed one coaccess electrode system was returned for analysis.Excessive residues were observed on the introducer cannula and electrode tines indicating use and handling of the device.The insulation in the introducer cannula does not have cuts, tears or any visible damage.No visual defects were noted with the electrode, the returned product looks under good conditions without evidence of damages or anomalies.A functional evaluation extended and retracted the tines without resistance.The tines were evenly spaced and undamaged.The introducer cannula and stylet were submitted to dimensional inspections both were found within specifications.
Event or Problem Description
It was reported a detachment occurred.The patient was undergoing a pulmonary radio frequency ablation procedure on an unknown date.During removal of the probe, the distal portion (1 cm long) remained stuck to the patient's lung.The procedure was stopped and surgery was performed to remove the detached portion of the probe.No further patient complications were reported.It was further reported that a detachment did not occur.Ablation of the patient's lung was successful; however removal difficulties occurred.The tines were retracted and the distal portion of the coaccess system was noted to be adhered to coagulated tissue of the lung.The device was able to be removed with difficulty noted.The device remained intact.There was no intervention required and there were no patient complications.

• 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: 8102046
• Report Number: 3005099803-2018-61496
• Device Sequence Number: 2267336
• Product Code: GEI
• UDI-Device Identifier: 08714729454939
• UDI-Public: 08714729454939
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140506
• 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): 02/07/2019

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: 02/11/2021
• Device Model Number: 36700
• Device Catalogue Number: 36700
• Device Lot Number: 0021731938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 11/26/2018
• Supplement Report FDA Received Date: 02/07/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention