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

Model Number	NV-7-30-HELIX
Medical Device Problem Code	Incomplete or Missing Packaging (2312)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that when the box was opened, the coil was pre-deployed in the packaging within the box.The coil was replaced with another one of the same size.The patient was undergoing treatment for a splenic artery embolization.There were no patient symptoms associated with the event.

• Brand Name: CONCERTO NYLON
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MEDTRONIC NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8179186
• Report Number: 2029214-2018-01083
• Device Sequence Number: 2024485
• Product Code: KRD
• UDI-Device Identifier: 00847536013643
• UDI-Public: 00847536013643
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 12/19/2018

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: 06/08/2020
• Device Model Number: NV-7-30-HELIX
• Device Catalogue Number: NV-7-30-HELIX
• Device Lot Number: A473497
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 63