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

Model Number 4FC12

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Air Embolism (1697); Paresis (1998); Respiratory Distress (2045); Seizures (2063)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Medtronic was made aware of this event through a search of literature publications.It was not possible to ascertain specific device information from the literature publication or to match the event with previously reported events.This information is based entirely on journal literature.This event occurred outside the us.All information provided is included in this report.Patient information is limited due to confidentiality concerns.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: ¿early hyperbaric oxygen therapy for cerebral air embolism during atrial fibrillation ablation.¿ doi: 10.1111/pace.13475.If information is provided in the future, a supplemental report will be issued.

Event Description

The literature publication reports the following patient complications while using a steerable sheath during the cryoablation procedure.The patient presented to the clinic for af ablation.After the steerable sheath was inserted, the guidewire and dilator were removed; and at the same time, the patient took a deep breath after a brief episode of apnea.Air was seen in the sheath.A large amount of air was taken out, but the patient developed ¿sudden respiratory distress.¿ the patient then has a ¿generalized tonic seizure.¿ there was also noted, dysarthria (speech slowness), and left-sided paralysis.The sheath was removed, and the procedure was stopped.The neurology department evaluated the patient, and the computerized tomography (ct) scan showed ¿several intracranial air embolic bubbles.¿ the patient was admitted to the intensive care unit.¿the patient was successfully treated with with hyperbaric oxygen (hbo) therapy and was discharged without any neurological sequelae.¿ of note, on the second day of hbo treatment, the dysarthris and hemiplegia had completely resolved.The air bubbles were also not seen on the second ct scan.The patient was discharged on the eighth day post-procedure.The status/location of the sheath is unknown.Further follow up did not yet yield any additional information.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

Additional information was obtained through follow up with the author who indicated that the "deep breathing of the patient caused air embolism." there was no additional intervention performed to the patient.Additionally, at the two-month follow up visit, the patient had not developed any additional complications.

• 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: 7870928
• MDR Text Key: 120096928
• Report Number: 3002648230-2018-00650
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2018
• 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: 51 YR