MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH; CATHETER, STEERABLE

Model Number 4FC12

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Bradycardia (1751); Cardiopulmonary Arrest (1765); Vasoconstriction (2126); Loss Of Pulse (2562); Vaso-Vagal Response (2661); Patient Problem/Medical Problem (2688); No Code Available (3191)

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: data files were returned and analyzed.Data files showed that 2 applications were performed with a balloon catheter without any issues.Multiple clinical issues were encountered during the procedure.The device was not returned for analysis and investigation.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.

Manufacturer Narrative

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

• Brand Name: FLEXCATH ADVANCE STEERABLE SHEATH
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7699374
• MDR Text Key: 114408817
• Report Number: 3002648230-2018-00494
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 00763000043773
• UDI-Public: 00763000043773
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123591
• 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,Followup
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2020
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 91122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2018
• 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
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 63 YR