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

Model Number 4FC12

Device Problem No Apparent Adverse Event (3189)

Patient Problems Cardiac Perforation (2513); Vascular Dissection (3160)

Event Date 06/23/2016

Event Type  Injury  

Event Description

It was reported that during a cryoablation procedure after several unsuccessful attempts to target the right inferior pulmonary vein (ripv) a probable dissection was observed at the outline of the left atrium near the ripv. The procedure was aborted; the patient was not under general anesthesia. The patient's vital signs were not impacted and a full recovery without extended hospitalization was achieved. No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Correction: event summary: the data files and sheath, 4fc12 with lot number 43233, were returned and analyzed. The data files did not show any system notices or issues for the date of the reported event. Visual inspection of the sheath showed that the device was intact with no apparent issues. A known clinical issue was encountered during the procedure. In conclusion, the sheath, 4fc12 with lot number 43233, passed the returned product inspection as per specification.

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.

• 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 CRYOCATH LP; 16771 chemin ste-marie; kirkland H9H 5 H3; CA H9H 5H3
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5806700
• MDR Text Key: 49944190
• Report Number: 3002648230-2016-00282
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 02/24/2018
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 43233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2016
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 07/19/2016 Patient Sequence Number: 1