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

Model Number 2ACH20

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Cardiopulmonary Arrest (1765); Low Blood Pressure/ Hypotension (1914); Muscle Spasm(s) (1966); Vasoconstriction (2126); Diminished Pulse Pressure (2606); Vaso-Vagal Response (2661)

Event Date 06/28/2018

Event Type  Injury  

Manufacturer Narrative

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 patient's heart rate decreased and asystole occurred.Pacing in the atrium was performed, and it was noted that there was capture however, there was no conduction through the av node.Cardiopulmonary resuscitation was subsequently performed, and it was observed that the patient did not have a pulse or blood pressure.Ventricular pacing was achieved, and epinephrine was administered.The patient's heart rate returned and the patient stabilized.An intracardiac echo (ice) and transthoracic echo were performed, and there was no effusion noted.A coronary angiogram was then performed, and spasm was noted in one of the left coronary arteries.The coronary spasm then resolved after a few minutes.The procedure was aborted, and the patient was under general anesthesia.The patient was extubated and taken into recovery.The patient was noted to be fully awake, with no signs of impairment.It was noted that physician felt that this event was a severe vagal responses from ablating a nerve ganglia.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the device and data files were returned and analyzed.Data files showed that 2 applications were performed with the balloon catheter without any issues.Visual inspection of the mapping catheter showed that the device was intact with no apparent issue.All 8 electrodes were available on the ring.Multiple clinical issues were encountered during the procedure.In conclusion, the mapping catheter passed the returned product inspection as per specification.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 7699385
• MDR Text Key: 114365616
• Report Number: 2182208-2018-01310
• 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,Followup,Followup
• Report Date: 10/02/2018

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: 02/07/2020
• Device Model Number: 2ACH20
• Device Catalogue Number: 2ACH20
• Device Lot Number: 10961714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2018
• Initial Date FDA Received: 07/18/2018
• Supplement Dates Manufacturer Received: 07/18/2018; 08/08/2018
• Supplement Dates FDA Received: 08/13/2018; 10/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2018
• 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: 2AF284 BALLOON CATHETER, 4FC12 SHEATH
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 63 YR