MAUDE Adverse Event Report: MEDTRONIC NEUROVASCULAR CONCERTO NYLON; DEVICE, EMBOLIZATION, VASCULAR

Model Number	NV-2-8-HELIX
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During evaluation, the concerto coil (lot# a559054) was removed from the opened concerto coil inner pouch.The concerto pushwire was found to be bent at approximately 0.5cm, 84.0cm, 119.0cm, and 122.5cm from the proximal end.The concerto pushwire was found to be outside of the introducer sheath.The concerto implant coil was found to be detached from the pushwire.The implant coil was found to be stretched and partially within the introducer sheath.The implant coil was partially extending out from the distal end of the introducer sheath.The portion of the implant coil outside of the introducer sheath was found to be partially stretched with a broken polypropylene filament.All other subassemblies appeared to be normal and no other anomalies were observed.During analysis of the concerto coil, no evidence was found that would ascribe root cause for the failure of the concerto coil from advancing through its introducer sheath.Additional testing: the outer diameter (od) of the concerto implant coil tip was measured and found to be within specification per d wgsnv-5-20-helix rev.J (spec¿s.= 0.0122¿ + 0.0010¿ / - 0.0025¿) coil tip od = 0.0111¿.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during coiling treatment, these two coils stuck inside their introducer sheath.It was reported that fist coil would not able to advance in the catheter hub as did not come out of the introducer sheath.Another same size of the coil was used but had the same issue.The physician used different size of the coils and procedure was completed.The patient is doing fine.All devices were used per the ifu.021 microcatheter was used but unknown microcatheter and hospital discarded.

• Brand Name: CONCERTO NYLON
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MEDTRONIC NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8138638
• Report Number: 2029214-2018-01026
• Device Sequence Number: 11202383
• Product Code: KRD
• UDI-Device Identifier: 00847536013346
• UDI-Public: 00847536013346
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K090046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/06/2018

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: 11/19/2020
• Device Model Number: NV-2-8-HELIX
• Device Catalogue Number: NV-2-8-HELIX
• Device Lot Number: A559054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 12/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1