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); Low Blood Pressure/ Hypotension (1914); Paralysis (1997); ST Segment Elevation (2059)

Event Date 04/19/2017

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 during a cryoablation procedure, while the competitor mapping catheter was inserted into the sheath, blood pressure dropped and st elevation was observed.An angiogram confirmed the presence of air in the right coronary artery.Air aspiration was attempted but the patient had a spasm.The patient was then transferred to another hospital, where magnetic resonance imaging (mri) scans of the head were negative for air.The patient regained consciousness and is able to speak, but has palsy and paralysis in four limbs.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The data files confirmed system notice 50012 ¿the refrigerant path is obstructed¿ unrelated to the clinical issue.The data files also showed multiple injections were performed.The sheath was not returned for investigation.A known clinical issue was encountered during the procedure (air embolism, hypotension and st elevation).If information is provided in the future, a supplemental report will be issued.

Event Description

It was further reported that the patient was transferred to the department of neurosurgery in another hospital and the patient still had aftereffects such as paralysis.

Manufacturer Narrative

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.

Manufacturer Narrative

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

Event Description

It was later reported the patient¿s pre-existing condition of sleep apnea syndrome in combination with insufficient sedation may have contributed to air entering 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: 6570538
• MDR Text Key: 75278289
• Report Number: 3002648230-2017-00229
• 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,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2017
• Initial Date FDA Received: 05/16/2017
• Supplement Dates Manufacturer Received: Not provided; 06/01/2017; 06/01/2017; 07/02/2018; 08/08/2018
• Supplement Dates FDA Received: 06/23/2017; 10/04/2017; 10/05/2017; 07/13/2018; 10/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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; Required Intervention
• Patient Age: 65 YR