MAUDE Adverse Event Report: COVIDIEN (IRVINE) MARATHON; CATHETER, CONTINUOUS FLUSH

Model Number 105-5056

Device Problem Radiation Underexposure (3018)

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

Event Date 03/03/2018

Event Type  malfunction  

Manufacturer Narrative

The device has been received.However, the device analysis is still underway.A supplemental report will be submitted.Linked events: 2029214-2018-00230, 2029214-2018-00231, 2029214-2018-00232.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that the marathon catheter distal marker visibility varied from another of the same lot.There was no patient injury.This event occurred in external carotid artery (eca) arteriovenous fistula (avf).

Manufacturer Narrative

The marathon micro catheter was returned for analysis within a shipping box; and within two plastic bags.Upon visual inspection, no issues were found with the marathon micro catheter hub, body or distal tip.No damages or irregularities were found with the distal marker band.No other anomalies were observed.Based on the device analysis and reported information, the report of poor marker band visualization could not be confirmed, and the cause could not be determined.The returned marathon evaluation did not reveal any evidence that the catheter was defective.There were no damages or issues found with the marker band that would have contributed to the reported issue.The lot history record showed no discrepancies that would have contributed to the reported experience.In addition, all products are 100% inspected for damages and irregularities during manufacture.Per the marathon ifu (instructions for use): ¿the catheter has a radiopaque marker at the distal end to facilitate fluoroscopic visualization.¿ if information is provided in the future, a supplemental report will be issued.

• Brand Name: MARATHON
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9492753836
• MDR Report Key: 7375633
• MDR Text Key: 103792812
• Report Number: 2029214-2018-00230
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K093750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2020
• Device Model Number: 105-5056
• Device Lot Number: A574348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2017
• 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