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

Model Number 4FC12

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

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Vaso-Vagal Response (2661)

Event Date 07/18/2018

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 appeared to have a vasovagal response, and it was noted that the blood pressure declined.The freeze was aborted, and the patient's blood pressure continued to drop.The heart rate then slowed, then subsequently turned to ventricular fibrillation.Cardiopulmonary resuscitation and advanced cardiovascular life support (acls) protocol were then initiated, and the patient was defibrillated.It was noted that a brief episode of pulseless electrical activity (pea) was observed.A transthoracic echocardiogram was performed, and the case was aborted.The patient was under general anesthesia.The patient had an extended hospitalization, and the patient was reported to be stable.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Event summary: the patient data files showed at least two injections were performed with catheter 2af284/49774 on the date of the event without triggering of any system notice.The sheath was not returned for further investigation.Clinical issues (cardiac arrest, hypotension, vasovagal reaction and the case aborted under general anesthesia) were encountered during the procedure.There is no sufficient evidence that the device potentially caused these adverse events.In conclusion, clinical issues (cardiac arrest, hypotension, vasovagal reaction and the case aborted under general anesthesia) were encountered during the procedure.The sheath was not returned for further investigation.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: 7779228
• MDR Text Key: 116994734
• Report Number: 3002648230-2018-00551
• 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
• Report Date: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 04482
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2018
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 59 YR