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

Model Number 4FC12

Device Problems Air Leak (1008); Fluid/Blood Leak (1250)

Patient Problems Low Blood Pressure/ Hypotension (1914); ST Segment Elevation (2059)

Event Date 05/31/2016

Event Type  Injury  

Event Description

It was reported that during a cryoablation procedure, the patient had st elevation and hypotension.An angiography was performed and it was discovered that the left anterior descending (lad) coronary artery was not fully filled with contrast media and it was blocked.It was noted that the physician suspected a leaking hemostatic valve which might have caused air ingress.After a while another angiography was performed; the lad was better visualized and filled with the contrast media.The patient's condition resolved and no intervention was performed.The case was aborted and no further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the sheath was returned and analyzed.Visual inspection of the sheath showed that the shaft was intact with no apparent issues and the reported air ingress could not be reproduced.Multiple aspirations and injections were performed without air bubbles or leaks.Also, the hemostatic valve and the valve assembly were leak tight.Clinical issues were encountered during the procedure.In conclusion, the reported air ingress issue was not confirmed through testing.

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 ; CA
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe claire,qc ; CA
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5751169
• MDR Text Key: 48247139
• Report Number: 3002648230-2016-00251
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 06/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2018
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 04256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/25/2016
• 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): Other