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

Model Number 2ACH20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombus (2101)

Event Date 11/02/2018

Event Type  Injury  

Manufacturer Narrative

Product event summary: the mapping catheter, 2ach20 with lot number 11023563 was returned and analyzed.Visual inspection of the mapping catheter showed the device was intact with no apparent issue.No ecg signal wires were broken inside the shaft and pins were in a good condition.The mapping passed the test as per specifications.In conclusion, the reported issue was not confirmed through testing.A clinical issue was encountered during the procedure.There was no indication of a product malfunction.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, when the mapping catheter was placed in the left inferior pulmonary vein (lipv) a ¿large, mobile clot¿ was seen at the end of the flex catheter.When prepping to remove the balloon catheter and mapping catheter to attempt aspiration the blood clot vanished and was no longer able to be seen.Angiographies were performed to try and locate the clot but it could not be found.The case was aborted while under general anesthesia.No further 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, 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: 8109386
• MDR Text Key: 128556221
• Report Number: 2182208-2018-02155
• 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: K162892
• 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: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2020
• Device Model Number: 2ACH20
• Device Catalogue Number: 2ACH20
• Device Lot Number: 11023563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2018
• Initial Date FDA Received: 11/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2018
• 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
• Treatment: 4FC12 SHEATH, 2AF284 MAPPING CATHETER
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 96