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

Model Number 105-5056

Device Problems Kinked (1339); Device Damaged by Another Device (2915)

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

Event Date 01/26/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received report that there was a hole at the distal marker of the marathon catheter after steam-shaping.This event occurred prior to a procedure.Marathon tip had been shaped only once for 10 seconds using the mandrel packaged with the catheter.It was reported that the catheter tip was not too close to the steam source.The tip was cooled in air or saline prior to removing the mandrel.The marathon catheter was not used on the patient.

Manufacturer Narrative

The marathon microcatheter was returned for analysis.Upon visual inspection, no issues were found with the marathon micro catheter hub.No kinks or bends were found with the body.The marathon micro catheter distal tip was found to be shaped which is consistent with the reported information.A hole in the tubing material was found at the proximal edge of the marker band.The hole appears to have been caused by melting.The marathon micro catheter was flushed, water exited from the hole and distal tip.Based on the device analysis and reported information, the report of catheter damage (hole) was confirmed.Although the root cause could not be determined, it is likely the distal tip became damaged during the shaping process.The lot history record review of the reported lot number showed no discrepancies that would have contributed to the reported experience; manufacturing has been ruled out as a potential cause.All products are 100% inspected for damages and irregularities during manufacture.The marathon ifu (instructions for use) provides the following guidance: ¿remove shaping mandrel from card and insert into distal tip of the catheter.Carefully bend catheter tip and shaping mandrel to desired shape.A slight over exaggeration of the shape may be required to accommodate for catheter relaxation.Shape the catheter by holding the shaped portion approximately 1 inch (2.5 cm not less than 1 cm) from the steam source for about 20 seconds (do not exceed 30 seconds).Allow catheter tip to cool in air or saline prior to removing mandrel.Remove mandrel from catheter and discard.Multiple shaping is not recommended.Inspect the tip for any damage that may have resulted from steam shaping the catheter.If any damage is found, do not use the catheter.¿ 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 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: 7392210
• MDR Text Key: 104251364
• Report Number: 2029214-2018-00245
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K093750
• 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
• Report Date: 05/22/2018

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: 08/13/2020
• Device Model Number: 105-5056
• Device Lot Number: A515744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2018
• Initial Date FDA Received: 04/03/2018
• Supplement Dates Manufacturer Received: 05/02/2018
• Supplement Dates FDA Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2017
• 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