MAUDE Adverse Event Report: COVIDIEN (IRVINE) CONCERTO NYLON; DEVICE, EMBOLIZATION, VASCULAR

Model Number NV-8-30-HELIX

Device Problem Difficult To Position (1467)

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

Event Date 03/02/2018

Event Type  malfunction  

Manufacturer Narrative

The reported device was received in a condition was contradictory to the complaint description (separation/detachment of implant coil).The customer did not report the detachment of the implant coil at the time of the event.Only the implant coil returned for investigation.The implant coil was found damaged and stretched with the polypropylene filament intact.Without the returned pushwire it is not possible to determine the cause of detachment.All coils are 100% inspected for damages and irregularities during manufacture.Follow-up was conducted to confirm the complaint details and that the correct device was returned.Information received and confirm that returned device is the correct device and but unknown about detachment of the implant coil from the pushwire.Per the concerto detachable coil and i.D.(instant detacher) instructions for use (ifu): precaution: "handle the axium detachable coil with care to avoid damage before or during treatment".If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during coiling treatment the loop was not formed.The coil did not position a lesion properly.The physician performed the procedure per the ifu.There was little bit more than normal resistance felt during the delivery of the coil in the catheter.No patient injury was reported.The procedure was completed with using new device.Total 5 coils were implanted in the patient.There was not any damage found on the implant coil.Evaluation of the returned device found that the implant coil was detached from the pushwire.The pushwire was not returned for investigation as it was discarded.

• Brand Name: CONCERTO NYLON
• Type of Device: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 7597182
• MDR Text Key: 110963538
• Report Number: 2029214-2018-00545
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K090046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2020
• Device Model Number: NV-8-30-HELIX
• Device Lot Number: A475718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2017
• 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