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 Low Blood Pressure/ Hypotension (1914); Dizziness (2194); Loss of consciousness (2418); Pericardial Effusion (3271)

Event Date 03/09/2017

Event Type  Injury  

Event Description

It was reported that during a cryo ablation procedure, the sheath was difficult to maneuver into the septum and a "twist" was suspected.Additionally, while trying to reach the right inferior pulmonary vein (ripv), the catheters dropped back into the right atria.Transeptal puncture was performed again and the catheters moved back into the left atria not allowing the sheath to be maneuvered.A dark area was observed at the shaft in fluoroscopy.The patient became unstable, dizzy, hypotensive, and lost consciousness.A pericardial effusion was confirmed.Pericardiocentesis was performed to drain the pericardia and the hospital stay was extended.The case was aborted and the patient was not under general anesthesia.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: clinical data files were received and reviewed.The files showed eight injections were performed with the balloon catheter.The sheath was returned and analyzed.Visual inspection of the sheath showed the shaft was kinked / twisted at 2.3435 inches from the tip.Functional testing showed the deflection mechanism was working fine and the pull wire was not broken.However, the deflection at the tip of the shaft was out of plane due to the kink/twist.The sheath failed the inspection due to a shaft kink/twist near the tip.

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: 6455691
• MDR Text Key: 71576090
• Report Number: 3002648230-2017-00151
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/07/2018
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 83522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2016
• 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: 73 YR