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); Bradycardia (1751); Cardiac Arrest (1762); Stroke/CVA (1770); Low Blood Pressure/ Hypotension (1914); ST Segment Elevation (2059)

Event Date 02/08/2017

Event Type  Injury  

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 when the cryo ablation procedure was complete, the balloon catheter was removed from the sheath and a competitor catheter was then inserted.It was then noted that the patient¿s heart rate and blood pressure dropped and st segments were verified to have gone up.Additionally, ¿temporary cardiac arrest was observed¿.Ventricular pacing was performed and the sheath was placed in the right atrium.It was then confirmed that air inclusion occurred and nitroglycerin was administered.Aspiration was then performed and a significant amount of air was aspirated.It was confirmed that the intrinsic rhythm had recovered and the blood pressure was stable.The case was completed with cryo.Following the procedure, mri scans of the head showed micro cerebral infarction, however, it was reported this was an expected symptom resulting from a cryoablation procedure.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the data files and sheath, 4fc12 with lot number 42972 were returned and analyzed.The data files confirmed system notice 50013 ¿the refrigerant level is too low to continue¿ unrelated to the clinical issue.The data files also showed multiple injections were performed.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.A clinical issue was encountered during the case.In conclusion, the sheath failed the returned product inspection due to a leaking hemostatic valve.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

Air embolism was confirmed."when the arctic front advance was removed from the flex cath advance, air inclusion occurred at the timing of insertion of other manufacturer's ring catheter.According to the physician, the cause was considered that the patient might have breathed deeply at the timing when the shaft of the ring catheter had been applying tension to the sheath, and at this time, large amount of air inclusion had been occurred at the gap of the sheath.".

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 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: 6377131
• MDR Text Key: 69042348
• Report Number: 3002648230-2017-00102
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2018
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 42972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2016
• 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): Life Threatening; Required Intervention