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

Model Number 4FC12

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 09/25/2017

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the data files for the date of the event were returned and analyzed. The files showed at least seventeen applications were performed with the balloon catheter without issue. The flexcath advance sheath, 4fc12 with lot 92460, was not returned for analysis. Therefore, the allegation of the sheath sterile barrier compromised could not be investigated. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product event summary: the flexcath advance sheath 4fc12, with lot number 92460 was returned and analyzed. Visual inspection of the package showed the sterile pouch barrier was opened. The sheath was intact with no apparent issues. The sheath distal tip and dilator tip were intact, no fracture, breakage or kink were noticed. There was no teflon delamination noticed at the tip of the sheath. Functional test of the sheath showed the deflection worked as per specification. In conclusion, the sterile barrier issue was confirmed through testing and the sheath¿s pouch was not sealed. If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, the sheath pouch was not properly sealed and it was noted the sterile barrier was broken. The sheath was 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: 6936779
• MDR Text Key: 105823482
• Report Number: 3002648230-2017-00556
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: AR
• 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: 03/26/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/28/2019
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 92460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial