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

Model Number 4FC12

Device Problem Air Leak (1008)

Patient Problems Air Embolism (1697); Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Paresis (1998)

Event Date 02/28/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during a cryoablation procedure, air was observed in the sideport of the sheath while the sheath was placed in the left atrium.The physician tried to aspirate but only air from the sheath valve was removed.An x ray was performed and the physician observed a massive air embolism in the patient's left atrium, left ventricle and aorta.The guide wire was removed and then it became possible to aspirate the air.It was noted that the patient experienced hemiparesis of the arm, very low la pressure and started to breath very deep.The physician reported that the valve of the sheath with the wire did not prevent air ingress.The procedure was aborted and the patent was hospitalized.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Event summary: visual inspection of flexcath sheath 4fc12 / 22147-097, results showed the device was intact with no apparent issues.Functional testing of the sheath confirmed the hemostatic valve was leaking.Air bubbles were observed through the valve.It was suspected that the valve disk was torn.This is a clinical issue encountered during the procedure.In conclusion, the reported (embolism, hypotension, shortness of breath, paralysis or paresis) issue cannot be confirmed through testing.The reported (air ingress during aspiration, hemostatic valve issue) issue was confirmed through testing.The reported (sideport aspiration issue) issue was not confirmed through testing.This is a clinical issue encountered during the procedure.The sheath failed the returned product inspection due to a leaking hemostatic valve.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: 7358760
• MDR Text Key: 103081657
• Report Number: 3002648230-2018-00169
• 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: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2019
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 22147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2017
• 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