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

Model Number 105-5096-000

Device Problem Material Separation (1562)

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

Event Date 02/21/2015

Event Type  malfunction  

Event Description

Medtronic (covidien) received information regarding an incident with one of its devices.During a procedure, the wire (agility 10-wire) that was inside the apollo micro catheter would not be advanced forward or moved backward.The catheter was removed to be inspected and the detachment part was noted to be separated and severely dented.No patient injury was reported as a result of the procedure.

Manufacturer Narrative

The device involved in the event has not been returned for evaluation.Requests have been made for reason for non-return, but without response.The lot history record of the reported lot number showed no discrepancies that might have contributed to the reported experience.(b)(4).

Manufacturer Narrative

The apollo catheter was returned for evaluation.The catheters useable length was measured to be within specification.The catheter was found to be bent and accordion like.The catheter was also found to be elongated with the guidewire protruding from the catheter tip for approximately 34.0cm.The detachable tip was found to be detached and found on the guidewire at approximately 2.8cm from the distal end of the guidewire.The detachable tip was measured to be within specification.The ldpe coupling tube overlap was measured to be within specification.The guidewire was removed from within the catheter lumen with slight resistance.No other anomalies were observed.The lot history records have been reviewed and no quality issues were noted.The tensile value for "low bond - 33.0" was reviewed and was within control limits of historical spc data.Based on the above findings the customer's report was confirmed.However, the cause for the damages could not be determined.All catheters are 100% inspected for damages and irregularities during manufacture.(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: 4631466
• MDR Text Key: 5573865
• Report Number: 2029214-2015-00279
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P030004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2015

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: 10/03/2017
• Device Model Number: 105-5096-000
• Device Lot Number: A002900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/27/2015
• Initial Date FDA Received: 03/25/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2014
• 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