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

Model Number 2ACH20

Device Problem Detachment Of Device Component (1104)

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

Event Date 02/16/2018

Event Type  malfunction  

Manufacturer Narrative

Patient files do not show any system notice on the date of the event.Visual inspection of 2ach20 / 10937160 showed the mapping catheter was ribbed and stripped pebax tubing and missing electrodes on the loop.The catheter failed the returned product inspection due to the ribbed/stripped pebax tubing and missing electrodes.The product analysis findings do not indicate a manufacturing related defect in conclusion, the reported issues were confirmed through the testing but not confirmed through the data analysis.The mapping catheter failed the returned product inspection due to the ribbed and stripped pebax tubing and missing electrodes on the loop.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 mapping catheter was unable to be correctly inserted into a competitor sheath.The competitor sheath and mapping catheter were removed from the patient.It was noted that the blue tubing around the mapping catheter had a tear in it.The catheter was then pulled back through the sheath outside the patient, and the blue material was fully stripped from the mapping catheter shaft.The mapping catheter was replaced with resolve, and the case continued and was completed with radiofrequency.No patient complications have been reported as a result of this event.On (b)(6) 2018: the mapping catheter was returned to the manufacturer, analyzed, and tested out of specification.

• Brand Name: ACHIEVE MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7496180
• MDR Text Key: 107701517
• Report Number: 2182208-2018-00862
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 00643169590984
• UDI-Public: 00643169590984
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102588
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/08/2018

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: 12/13/2019
• Device Model Number: 2ACH20
• Device Catalogue Number: 2ACH20
• Device Lot Number: 10937160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2018
• Initial Date FDA Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2017
• 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