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

Model Number 4FC12

Device Problem Air Leak (1008)

Patient Problems Neurological Deficit/Dysfunction (1982); ST Segment Elevation (2059)

Event Date 11/04/2016

Event Type  Injury  

Manufacturer Narrative

Data files showed there were no injections.Physical product analysis is pending.

Event Description

It was reported that during a cryoablation procedure, after introduction of the sheath into the left atrium, st-elevation occurred.It was noted that the physician assumed air bubbles were introduced from the sheath.The sheath was replaced.The st-elevation persisted after introduction of the second sheath.The physician also noted more air aspiration than usual after insertion of both sheaths.The patient developed neurological deficits and the procedure was aborted.The patient did fully recover after an extended hospital stay.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the sheath was visually inspected and functionally tested.Visual inspection of the sheath showed the stopcock was intact with no apparent issues.Air aspiration was reproduced when a test catheter was introduced through the sheath.Dissection showed the hemostatic valve was leaking; the valve was torn.Clinical data files were also returned and analyzed; the files did not show any injections.

• Brand Name: FLEXCATH ADVANCE STEERABLE SHEATH
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 16771 chemin ste-marie; kirkland H9H 5 H3; CA H9H 5H3
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 16771 chemin ste-marie; kirkland H9H 5 H3; CA H9H 5H3
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6135009
• MDR Text Key: 61139269
• Report Number: 3002648230-2016-00505
• 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
• Report Date: 11/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2018
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 92123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2016
• 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: 4FC12 SHEATH
• Patient Outcome(s): Hospitalization