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

Model Number 4FC12

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Patient Involvement (2645)

Event Date 08/01/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The literature publication reported the following product performance issue during the ex vivo study of a cryoballoon ablation balloon and steerable sheath catheter: air bubbles were seen during the simulation of the ablation procedure.Of note, multiple manufacturers/multiple methods were noted in the article: radio frequency ablation and cryoballoon ablation.A silicone heart model was used for the procedure, and ¿all manipulations replicated the actual clinical procedures conducted at the hospital.¿.There were small and large air bubbles noted during the procedure: at the time of sheath flushing, and prior to the time of inserting the balloon into the sheath.It was also noted that the balloon was ¿massaged¿ in a saline solution to remove the air bubbles.The author concludes by indication, ¿air bubbles enter the la at specific times during rf catheter and cb ablation procedures; however, this intrusion can be reduced using several techniques and different conditions.¿.There was no patient involvement.Further follow up did not yet yield any additional information.

• 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: 8065759
• MDR Text Key: 128044502
• Report Number: 3002648230-2018-00830
• 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: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2018
• 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