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

Model Number 4FC12

Device Problem Suction Problem (2170)

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

Event Date 01/21/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, while aspirating the sheath, there was a lot of air introduced.The air was visible on fluoroscopy.The sheath was replaced and the procedure was completed with cryo.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the device, flexcath advance sheath 4fc12 with lot number 31829 (b)(4), and data files were returned and analyzed.The data files did not show any issues.Visual inspection of the sheath demonstrated the shaft was intact with no apparent issues.Multiple aspirations and injections were performed without air bubbles or leaks.The hemostatic valve and valve assembly were leak tight.In conclusion, the reported air ingress has not been confirmed through testing and could not be reproduced.The returned product passed the returned product inspection per specification.

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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5521192
• MDR Text Key: 148535272
• Report Number: 3002648230-2016-00045
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/25/2017
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 31829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2015
• 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
• Patient Age: 40 YR