MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 CONCERTO NYLON; DEVICE, EMBOLIZATION, VASCULAR

Model Number	NV-6-20-HELIX
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The concerto was returned for analysis.The concerto implant coil pushwire was found to be broken into two segments.The first segment was broken at break indicator with release wire intact.The second segment was broken at distal end of pushwire with release wire protruding ~0.6cm from broken distal end.The implant coil was found to be detached and not returned.Under the microscope, the coin was not found to be located against the lumen stop, and the shield coil was found to be present.Based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ could not be confirmed and the root cause could not be determined.The returned pushwire was found to be broken.It is possible that the damage to the pushwire occurred during the attempt to push the coil through the micro catheter against the reported resistance; however, the root cause could not be determined.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report of concerto resistance in a catheter during a procedure.The concerto was not implanted in the patient.There were no reports of patient injury.The devices had been prepared and used per the instructions for use (ifu).A continuous flushed was not used during the procedure.The concerto was returned and the pushwire was observed to be separated.

• Brand Name: CONCERTO NYLON
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8512647
• Report Number: 2029214-2019-00345
• Device Sequence Number: 16590379
• Product Code: KRD
• UDI-Device Identifier: 00847536013582
• UDI-Public: 00847536013582
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K090046
• 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
• Report Date (Section B): 04/14/2019

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: 02/08/2020
• Device Model Number: NV-6-20-HELIX
• Device Lot Number: A411820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 04/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1