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 Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Ventricular Fibrillation (2130); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 11/13/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that four hours post cryoablation procedure, the patient's blood pressure declined and cardiac tamponade occurred.Ventricular fibrillation was also observed, and it was noted that the bleeding site was the right inferior pulmonary vein (ripv).Cardiac massage, open chest surgery and arrest of hemorrhage was then performed.It was also reported that pericardial effusion was observed via echocardiogram, and the effusion was aspirated by drainage.Blood pressure recovered, and the patient was transferred to the intensive care unit (icu).The patient's hospitalization was extended.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 seventeen injections were performed with the catheter and inflation could not be sustained at many injections.In conclusion, clinical issues were encountered during the procedure.The device was not returned for 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: 7082905
• MDR Text Key: 93728125
• Report Number: 3002648230-2017-00667
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 01/23/2018

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: 08/16/2019
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 43611
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2017
• Initial Date FDA Received: 12/05/2017
• Supplement Dates Manufacturer Received: 01/02/2018
• Supplement Dates FDA Received: 01/23/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/16/2017
• 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
• Treatment: BALLOON CATHETER, 2AF284
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 64