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 Bradycardia (1751); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513)

Event Date 06/11/2018

Event Type  Injury  

Manufacturer Narrative

Event summary: the returned patient data files showed at least six applications were performed with catheter 2af284/91556 on the date of event with no issue.Failure file did not show any system notice triggered on the event date.This is a clinical issue encountered during cryoablation procedure.Visual inspection of the sheath, 4fc12 / 04473, showed a deformation at the tip of the shaft.Functional testing of the sheath showed deflection worked as per specification.In conclusion, this is a clinical issue (bp, hr, hemorrhage, arrest) encountered during a cryoablation procedure.The sheath failed the returned product inspection due to a shaft tip deformation.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that following a cryo ablation procedure, the sheath was in the process of being removed and the patients blood pressure and heart rate dropped significantly.Atropine was administered without resolve.The sheath was inserted back into the right ventricle and it was perforated.It was then indicated that cardiac arrest occurred.Cardiac massage was performed and percutaneous cardiopulmonary support (pcps) was attached to the patient to maintain circulatory dynamics.The bleeding was unable to be stopped and an emergency operation was performed and hemostasis was performed successfully.It was confirmed that the hemorrhage sites were on the right ventricle and around the left superior pulmonary vein (lspv) ostium of the left atrium.The case was already completed with cryo.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

Incoming information received indicated that the patient had an extended hospitalization, and remains in the hospital with a stable condition at this time.

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: 7655137
• MDR Text Key: 112886442
• Report Number: 3002648230-2018-00455
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 04473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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: 78 YR
• Patient Weight: 51