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

Model Number 105-5096-000

Device Problem Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/11/2015

Event Type  Injury  

Manufacturer Narrative

The device has not been returned for evaluation.The lot history record of the reported lot number has been reviewed and no quality issues were noted.(b)(4).

Event Description

The following report was received by medtronic (covidien): the apollo microcatheter was navigated along afferent artery and before locating the nest of the arteriovenous malformation (avm) in the left occipital region, the 3 cm tip sailed; and stayed in the trajectory of the artery and remained lodged in the external carotid artery.The tip remains in the patient.There was no surgical or medical intervention required and there was no patient injury.The doctor used another apollo microcatheter and was navigated to the (avm) through another afferent artery.Patient was discharged from the hospital.

Manufacturer Narrative

The apollo catheter was returned for investigation with without the detachable tip as it remains inside the patient.The competitor's guidewire mentioned in the complaint description was not returned; therefore, any contributing factors from the guidewire could not be assessed.It was confirmed that the tip of the catheter was detached from the catheter.No other defects were noted on the catheter body.No other anomalies were observed.Based on the reported information the guidewire used has a distal o.D (outer diameter) of 0.007" and a proximal od of 0.012" which is incompatible with the apollo catheter.In addition all products are 100% inspected for damage and irregularities during manufacture.Note: as per the apollo ifu (instructions for use): the apollo is not compatible with non-hydrophilically coated guidewires or guidewires greater than 0.010" in diameter.(b)(4).

• 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: 5065008
• MDR Text Key: 25318065
• Report Number: 2029214-2015-00951
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: P030004/S006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/04/2018
• Device Model Number: 105-5096-000
• Device Lot Number: A053174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2015
• 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
• Patient Age: 24 YR
• Patient Weight: 93