MAUDE Adverse Event Report: MEDTRONIC MEXICO ACHIEVE MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 990063-020

Device Problem Knotted (1340)

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

Event Date 09/29/2017

Event Type  malfunction  

Manufacturer Narrative

Event summary: the patient data files showed four injections were performed with catheter 2af283/12131-21 without any issues or system notices.Upon visual inspection of achieve mapping catheter 990063-020 / 213478292, results showed the loop array was damaged and a knot was observed 0.62in from the tip.Furthermore, the catheter shaft was broken 11 inches from the tip.Additional inspection under microscope did not revealed any kink on pebax shaft.The reported issue does not indicate a mapping catheter¿s manufacturing related defect.In conclusion, the reported issue (achieve tip damage/broken) was confirmed through testing.The mapping catheter failed the returned product inspection due to a damaged tip/loop section and broken shaft.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, the tip of the mapping catheter broke when it was pulled back into the sheath for additional ablation.The broken end of catheter were successfully removed with the sheath, as confirmed via xray.The case was completed with cryo.The mapping catheter was returned to the manufacturer, analyzed, and tested out of specification.No patient complications have been reported as a result of this event.

• Brand Name: ACHIEVE MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7237496
• MDR Text Key: 98996784
• Report Number: 9612164-2018-00194
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• PMA/PMN Number: K102588
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 02/02/2018

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: 05/31/2019
• Device Model Number: 990063-020
• Device Catalogue Number: 990063-020
• Device Lot Number: 213478292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2017
• Initial Date Manufacturer Received: 12/08/2017
• Initial Date FDA Received: 02/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2017
• 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
• Patient Age: 34 YR