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

Model Number NV-7-30-HELIX

Device Problem Incomplete or Missing Packaging (2312)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/30/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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
• Type of Device: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MEDTRONIC NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MEDTRONIC NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 7635263305
• MDR Report Key: 8179186
• MDR Text Key: 130853038
• Report Number: 2029214-2018-01083
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00847536013643
• UDI-Public: 00847536013643
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K090046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/30/2018
• Date Device Manufactured: 06/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 63