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

Model Number 4FC12

Device Problem Fluid Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

The sheath 4fc12 with lot number 001027449 was returned and analyzed. Visual inspection of the sheath showed the device was intact with no apparent issue. Performance test with sentinel blackbelt leak tester revealed the pressure decay (2. 50 psig) is more than acceptance range (less than 0. 945 psig). Air aspiration was reproduced during the aspiration test when a test balloon catheter was introduced through the sheath. The hemostatic valve was leaking; we suspect the valve disk is torn. Further dissection did not show any leak along the shaft in the handle. The compatibility test was performed with a test catheter and it passed through the sheath, however some stiffness verified while trying to insert the catheter inside the sheath in the hemostatic valve. In conclusion, the sheath failed the returned product inspection due to a leaking hemostatic valve. If information is provided in the future, a supplemental report will be issued.

Event Description

After a completed case, the sheath subsequently tested out of specification per the manufacturer's investigation.

• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 11252309
• MDR Text Key: 230484084
• Report Number: 3002648230-2021-00049
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 01/29/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 0010274491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2020

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial