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); Stroke/CVA (1770); Death (1802); Embolism (1829); ST Segment Elevation (2059); Confusion/ Disorientation (2553)

Event Date 07/18/2017

Event Type  Death  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryoablation procedure, air ingress occurred during aspiration and resulted in a coronary embolism.The case was aborted while the patient was under general anesthesia.The patient was sent to another hospital for special surveillance regarding potential brain embolism.The patient¿s hospitalization was extended two days.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

It was further reported that the cause of death was a cerebral hemorrhage.

Manufacturer Narrative

Product event summary: the sheath, 4fc12 with lot number 48894 was returned and analyzed.Visual inspection of the sheath showed the device was intact with no apparent issues.Air aspiration was reproduced when a test balloon catheter was introduced through the sheath.Dissection showed the hemostatic valve was leaking and it was torn.In conclusion, the reported air ingress issue was confirmed through testing.The sheath failed the returned product inspection due to a leaking hemostatic valve.Also, a clinical issue (embolism) was encountered and it was not confirmed through testing.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

(b)(6) 2018: incoming information indicated that the patient had died following the case.Further details are unknown at this time.

Manufacturer Narrative

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

Event Description

It was further reported that the patient experienced st elevation, an air embolism and disoriented.Also, it was noted that the cerebral hemorrhage was due to the patient's condition.As the patient had an uncontrolled inr from an anticoagulation regimen.

• 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: 6770362
• MDR Text Key: 81923349
• Report Number: 3002648230-2017-00426
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup,Followup
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2019
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 48894
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/09/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2017
• 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): Death; Hospitalization; Life Threatening