MAUDE Adverse Event Report: COVIDIEN (IRVINE( ONYX LES; AGENT, INJECTABLE, EMBOLIC

Model Number 105-7100-060

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/19/2017

Event Type  malfunction  

Manufacturer Narrative

The onyx was not returned for evaluation as it was consumed in the event and remains in the patient.The cause of the reported event cannot be reliably determined.However, based on the reported information, there is no evidence suggesting that the device was defective, but rather a procedure related event.Mdrs from this event: 2029214-2017-00875.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the apollo catheter broke proximal to the detachment point when retracting after onyx was delivered.No injury reported.The patient was receiving onyx embolization to treat a fistula that was fed from 3 areas.The reported device and accessory devices were prepared per the ifu and the catheter was flushed as indicated.There was no friction or difficulty during injection and injection waiting time was no longer than 2 minutes at a time.Injection was stopped when reflux on the catheter began to occur.The reflux was slightly proximal to the proximal marker of the microcatheter.Several short injections were performed after the reflux was observed.Force was applied during removal of the microcatheter and the tip was entrapped.The broken segment remains in the occipital artery.

• Brand Name: ONYX LES
• Type of Device: AGENT, INJECTABLE, EMBOLIC
• Manufacturer (Section D): COVIDIEN (IRVINE(; 9275 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE(; 9275 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 6699896
• MDR Text Key: 79601553
• Report Number: 2029214-2017-00876
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/19/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2019
• Device Model Number: 105-7100-060
• Device Lot Number: A241092
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2017
• Initial Date FDA Received: 07/10/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/10/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1