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

Model Number 4FC12

Device Problem Occlusion Within Device (1423)

Patient Problems Air Embolism (1697); Cardiac Arrest (1762); Occlusion (1984); ST Segment Elevation (2059)

Event Date 12/02/2015

Event Type  Injury  

Manufacturer Narrative

This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.(b)(4).

Event Description

It was reported that during a cryoablation procedure, after extracting a competitor mapping catheter that was directly inserted into the sheath, the balloon catheter was reinserted into the sheath's hemostatic valve and less than expected resistance was noted by the physician.The procedure continued, and after the remaining potentials were ablated, the balloon catheter was removed from the patient's body.The competitor mapping catheter was advanced to check the pulmonary vein (pv) isolation; the patient's blood pressure decreased and cardiac arrest occurred.Cardiac massage was performed and the patient recovered.After, st elevation was confirmed and a coronary angiography (cag) was performed.The cag confirmed that there was no blood flow in the right coronary artery (rca) and complete occlusion occurred.Nitrol was administered; the blood flow recovered and st returned to normal.Pv isolation was then confirmed, and the case was completed with cryo.It was noted that the physician considered the complications due to air ingress when the competitor mapping catheter was inserted into the sheath.Further information obtained reported that the patient experienced a change in conversational skills the morning after the procedure; the patient was only responding "yes" to all questions.The patient was diagnosed with cerebral edema; a tracheostomy was performed and the patient was placed under deep sedation.The patient recovered consciousness the next day and began regaining cognitive function.It was noted that the patient has since fully recovered and has been moved to the general ward in the hospital for observation.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the data files for the date of the reported event were returned and analyzed.The data files did not show any system notices for the reported event date.No product was returned for investigation; therefore, no investigation was possible for the reported issue of air ingress with the flexcath sheath (model 4fc12, lot number 66031).Several clinical issues were encountered during the procedure.In conclusion, no product was returned for investigation; thus the reported issue of air ingress could not be investigated.Several clinical issues were encountered during the procedure.

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

On (b)(6) 2017, 09:52:12: the cerebral edema was the result of an air embolism, per the physician.

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; 16771 chemin ste-marie; kirkland H9H 5 H3; CA H9H 5H3
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5310298
• MDR Text Key: 33869691
• Report Number: 3002648230-2015-00462
• 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
• Report Date: 12/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2017
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 66031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2015
• 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