MAUDE Adverse Event Report: COVIDIEN (IRVINE) APOLLO; AGENT, INJECTABLE, EMBOLIC

Model Number 105-5096-000

Device Problem Material Separation (1562)

Patient Problem No Information (3190)

Event Date 10/17/2014

Event Type  Injury  

Event Description

Treatment of an avm (arteriovenous malformation).On (b)(6) 2014, the patient underwent onyx embolization treatment.During the procedure, it was reported the tip of the apollo catheter separated as it was being advanced to the lesion.No further information was available.

Manufacturer Narrative

The device involved in the event has not been returned for evaluation.

Manufacturer Narrative

Received additional information stating that the tip of the apollo remains in the patient.No patient injury was reported.Reference (b)(4) follow-up 1.

Manufacturer Narrative

The apollo catheter was returned for investigation without the detachable tip as it remains in the patient.It was confirmed that the tip of the catheter was detached from the catheter.The evaluation showed that the device was within specifications.The lot history record review of the reported lot number showed no discrepancies that might have contributed to the reported experience.All products are 100% inspected for damage and irregularities during manufacture.(b)(4).

• Brand Name: APOLLO
• Type of Device: AGENT, INJECTABLE, EMBOLIC
• 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 ; 9496801224
• MDR Report Key: 4275724
• MDR Text Key: 19346486
• Report Number: 2029214-2014-00679
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: VE
• PMA/PMN Number: P030004/S006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2015
• Device Model Number: 105-5096-000
• Device Lot Number: 9685378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2012
• 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
• Patient Outcome(s): Disability