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

Model Number	36700
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle did not deploy properly.The leveen coaccess needle was being used for a procedure.When the needle was deployed it was noted that it had not deployed properly.No patient complications were reported.
Event or Problem Description
It was reported that the needle did not deploy properly.The leveen coaccess needle was being used for a procedure.When the needle was deployed it was noted that it had not deployed properly.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: one rf probe was received with its tines in closed/retracted position.No visual defects were noted, the returned product looks under good conditions without evidence of damages or anomalies.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; consequently, not confirming the reported complaint.

• 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: 8339529
• Report Number: 2134265-2019-01261
• Device Sequence Number: 14010573
• Product Code: GEI
• UDI-Device Identifier: 08714729295617
• UDI-Public: 08714729295617
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140505
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2019

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: 09/25/2021
• Device Model Number: 36700
• Device Catalogue Number: 36700
• Device Lot Number: 0022706616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Initial Date Received by Manufacturer: 01/21/2019
• Supplement Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 04/09/2019
• Patient Sequence Number: 1