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

Model Number 4FC12

Device Problem Gas/Air Leak (2946)

Patient Problems Embolism (1829); Low Blood Pressure/ Hypotension (1914); Paralysis (1997); ST Segment Elevation (2059); Ventricular Tachycardia (2132)

Event Date 07/07/2020

Event Type  Injury  

Manufacturer Narrative

Product event summary: the 4fc12 sheath with lot 0010130780 was returned and analyzed.Visual inspection showed the shaft was intact with no apparent issues.Multiple aspirations and injections were performed without air bubbles or leaks, and the hemostatic valve was leak tight.The reported air ingress issue could not be reproduced.The clinical issues (st elevation, ventricular tachycardia, hypotension, transient paralysis of the left side of the body, and air embolism) occurred during the case.In conclusion, the reported air ingress issue was not confirmed through testing.There is no indication of a relation of the adverse events to the performance and malfunction of the product.The sheath passed the returned product inspection as per specification.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, transeptal access was lost and the sheath was exchanged.St elevation, ventricular tachycardia, and hypotension were all observed.A cardioversion was performed and pressure was supported with anesthesia.Slowly the st elevation went down.The case was aborted.Upon awaking from the procedure, the patient displayed a transient paralysis of the left side of their body which later recovered.A computed tomography scan of the brain was performed.An air embolism, indicating air ingress occurred at one point, was suspected.The patient's hospitalization was extended.No further patient complications have been reported as a result of this event.

• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10328497
• MDR Text Key: 200601643
• Report Number: 3002648230-2020-00377
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2022
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 0010130780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2020
• 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: 52 YR