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

Model Number 4FC12

Device Problems Gas/Air Leak (2946); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during a cryo ablation procedure, when the sheath was aspirated, air ingress occurred at the hemostatic valve; the physician suspected the valve was defective.The sheath was replaced to resolve the issue.The case was completed with cryo.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the 4fc12 sheath with lot number 0010170932 was returned and analyzed.Visual inspection of the sheath showed the sheath was intact with no apparent issues.Leak testing was performed using a sentinel blackbelt leak tester, and the sheath passed the test.In conclusion, the reported air ingress and the hemostatic valve issue were not confirmed.The sheath passed the returned product inspection as per specification.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
• MDR Report Key: 10638225
• MDR Text Key: 210201221
• Report Number: 3002648230-2020-00533
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2022
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 0010170932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Date Manufacturer Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1