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

Model Number 105-5096-000

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

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

Event Date 06/20/2018

Event Type  malfunction  

Manufacturer Narrative

The apollo microcatheter has not been returned for evaluation; product analysis cannot be performed.The device was not returned, therefore the reported event could not be confirmed.The cause of the event cannot be conclusively determined from the provided information.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during arteriovenous malformation (avm) embolization, the apollo catheter tip detached prematurely.It was reported that the physician flushed the microcatheter, when began to pass the medtronic guidewire, found catheter tip detachment.The physician used another same microcatheter and completed the procedure.The vessel was normal tortuous.No patient injury was reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The device was returned for evaluation and the clinical observation was confirmed.As received, the apollo catheter found that the 3.0cm detachable tip detached from the catheter.The apollo usable length was found within specifications.There were not any kink or bends found on the apollo microcatheter.No damages or irregularities were found with the detached tip.Based on the device analysis and reported information, we were unable to determine the cause of ¿tip premature detachment¿.It is possible the tip became weakened during handling subsequently causing the tip to detach upon insertion of the guidewire.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.All products are 100% inspected for damages and irregularities during manufacture.Per the apollo ifu (instructions for use): ¿inspect the catheter, taking care to not touch or manipulate the tip prior to use to verify that it is undamaged.Always handle the distal end of the catheter with care to avoid damage to the detachment zone and unintended detachment.¿ if information is provided in the future, a supplemental report will be issued.

• Brand Name: APOLLO CATHETER
• 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 ; 9498373700
• MDR Report Key: 7711473
• MDR Text Key: 114949726
• Report Number: 2029214-2018-00643
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: Initial,Followup,Followup
• Report Date: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2020
• Device Model Number: 105-5096-000
• Device Lot Number: A497652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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