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 ST Segment Elevation (2059); Ventricular Fibrillation (2130)

Event Date 09/21/2016

Event Type  Injury  

Event Description

It was reported that during a cryoablation procedure, after insertion of the balloon catheter into the sheath, st elevation was noticed followed from a slow-down of sinus rhythm (sr) and change of rhythm to ventricular fibrillation.After cardioversion and application of suprarenin, the patient was stabilized in normal sr.Five minutes later the st elevation vanished.The sheath was replaced with one of a new lot and the case was completed with cryo.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Event summary: upon visual inspection of flexcath sheath 4fc12 / 09419-073, results show the device intact with no apparent issues.Multiple aspirations and injections were performed without air bubbles or leaks.The hemostatic valve was leak tight.The valve assembly was leak tight as well.In conclusion, this is a clinical issue encountered during the procedure only.

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; point claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; point 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: 6035293
• MDR Text Key: 57680737
• Report Number: 3002648230-2016-00440
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2018
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 09419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/28/2016
• 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
• Treatment: 09419, SHEATH
• Patient Outcome(s): Life Threatening; Required Intervention