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

Model Number 105-5096-000

Device Problems Material Separation (1562); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/19/2014

Event Type  Injury  

Event Description

The following report was received by medtronic (covidien) through receipt of a medwatch uf/importer report number (b)(4).During treatment of a brain arteriovenous malformation (bavm) with ev3 onyx embolic system, the end of the apollo catheter broke off.The catheter fragment stayed in the patient extending from the proximal cervical right ica into the right mca superior division branch.Additional information was received through follow up.It was indicated that there was reflux past the detachment zone.The pause between injections was 2 min.There was no surgical or medical intervention and the patient was neurologically intact.Two lot numbers for the onyx were reported, it is unknown which of the two caused or contributed to the catheter entrapment.

Manufacturer Narrative

The lot history record of the reported lot number has been reviewed and no quality issues were noted.The onyx was not returned for evaluation as it was consumed in the event.Based on the reported information, there is no evidence suggesting that the onyx was defective, but rather a procedure related event.Note: per the onyx ifu (instructions for use) warnings: do not allow more than 1 cm of onyx les to reflux back over catheter tip.Excessive onyx reflux may result in difficult catheter removal and catheter entrapment.Per the apollo ifu (instructions for use) warnings: leave a gap between the reflux and the proximal marker band.Excessive reflux may result in difficult catheter removal.Reference (b)(4).Information received from the same article as mfrs: 2029214-2015-00796.2029214-2015-00798.

Manufacturer Narrative

Additional information was received indicating that the 3 cm tip along with 10 to 15 cm of the apollo catheter remains in the patient.(b)(4).

Manufacturer Narrative

Investigation results for catheter corrected: the apollo catheter was not returned for analysis (not onyx as mentioned in the original report).Therefore; the event cause could not be determined.In addition, the lot history record review was not possible since the lot number for the apollo catheter was not provided.Note: per the apollo ifu (instructions for use) warnings: leave a gap between the reflux and the proximal marker band.Excessive reflux may result in difficult catheter removal.Reference (b)(4) - follow up 2.

• Brand Name: APOLLO MICROCATHETER
• 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: 4932516
• MDR Text Key: 6054799
• Report Number: 2029214-2015-00797
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030004/S006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 105-5096-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Disability
• Patient Age: 24 YR