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

Model Number 4FC12

Device Problems Air Leak (1008); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/08/2017

Event Type  malfunction  

Event Description

It was reported that during a cryo ablation procedure, the flow was confirmed to be slightly unstable.Also, it was noted that there was something wrong with the way the temperature declined.Furthermore, the pressure was higher than usual.The coaxial umbilical cable was replaced with resolve.It was also reported that after the balloon catheter was inserted and air was removed from the side port of the sheath, air was continuously observed.A valve anomaly was suspected.The sheath was replaced with resolve.The case was completed with cryo.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: clinical data files were received and reviewed.The reported valve issue was not confirmed through data analysis.Pending results of the analysis on returned product.

Manufacturer Narrative

Product event summary: the sheath, 4fc12 with lot number 67923, was returned and analyzed.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.Dissection showed the hemostatic valve was leaking; valve was torn.In conclusion, the reported issue was confirmed through analysis.The sheath, 4fc12 with lot number 67923, failed the returned product inspection due to a leaking hemostatic valve.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.

• 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: 6449702
• MDR Text Key: 71465242
• Report Number: 3002648230-2017-00143
• 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: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/10/2018
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 67923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2016
• 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