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 Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: approximated.
Event or Problem Description
It was reported that deployment issues occurred and the array was damaged.A 3.0/15/15 leveen coaccess was selected for use in a radiofrequency ablation procedure of the patient's lung.It was noted that the tines of the array did not deploy or retract properly resulting in them becoming twisted.No patient complications were reported.
Additional Manufacturer Narrative
Date of event: approximated.
Event or Problem Description
It was reported that deployment issues occurred and the array was damaged.A 3.0/15/15 leveen coaccess was selected for use in a radiofrequency ablation procedure of the patient's lung.It was noted that the tines of the array did not deploy or retract properly resulting in them becoming twisted.No patient complications were reported.Device evaluated by mfr: examination of the returned product revealed one coaccess electrode system was received.Inspection verified that the tip of unit was not damaged, however it was returned with the tines partially opened.No visual defects were noted, the returned product appears in good condition without evidence of damage or anomalies.Functional inspection revealed the handle was actuated moving it forward and backward and the tines of the returned device could be extended and retracted properly without problems or resistance.

• Brand Name: LEVEEN COACCESS
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7935003
• Report Number: 2134265-2018-61596
• Device Sequence Number: 1654345
• Product Code: GEI
• UDI-Device Identifier: 08714729454922
• UDI-Public: 08714729454922
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 11/14/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/15/2021
• Device Model Number: 36700
• Device Catalogue Number: 36700
• Device Lot Number: 0022379440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2018
• Initial Date Received by Manufacturer: 09/07/2018
• Supplement Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 10/04/2018
• Supplement Report FDA Received Date: 11/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1