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

Model Number 4FC12

Device Problem Air Leak (1008)

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

Event Date 07/25/2017

Event Type  malfunction  

Manufacturer Narrative

Event summary: the patient data files showed at least six injections were performed with catheter 2af284 / 12130-81 on the date of the event without any system notice. Failure file did not show any system notice triggered on the date of the event. Upon visual inspection of the flexcath sheath 4fc12 / 70121-055, results showed the device was intact with no apparent issues. Air aspiration was reproduced when a lab test catheter was introduced through the sheath. Dissection showed the hemostatic valve was leaking. In conclusion, the reported air ingress issue was confirmed through testing but not confirmed through the data analysis. The catheter passed the returned product inspection as per specification. The sheath failed the returned product inspection due to a leaking hemostatic valve.

Event Description

It was reported that during a cryo ablation procedure, the balloon catheter was inflated outside of the patient¿s body and air was a spirated. When the balloon catheter was inserted into the sheath, air was introduced and ¿more resistance than usual¿ was observed. It was noted that neither the balloon catheter nor the sheath were replaced. The case was completed with cryo. No patient complications have been reported as a result of this event.

• 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: 6818486
• MDR Text Key: 83658976
• Report Number: 3002648230-2017-00461
• 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

• Type of Report: Initial
• Report Date: 07/28/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/15/2019
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 70121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial