MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number UNKNOWN

Device Problems Failure to Advance (2524); Temperature Problem (3022)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

A biosense webster lassostar (20mm) was being used in our afapr028 cryoballoon.Upon cannulation of the first vein (ripv) with the lassostar, the physician noted that the lassostar was difficult to manipulate (i.E.Move in and out of the balloon lumen).Shortly after that it was noticed that the egm associated with electrode 3 was not working (bad/messy signal).An initial freeze was attempted after placement of the balloon in the ripv, but was abandoned due to ineffective temperatures.Upon attempt to reposition the balloon and re-cannulate the ripv, it became increasingly difficult to get the lassostar pulled into the balloon lumen.At this time, the balloon was "forced" with a strong pull back into the balloon lumen, but was unable to be re-advanced.At this time, the physician pulled the entire balloon and lassostar system out of the flexcath sheath and out of the patients body for inspection.Upon pulling the lassostar fully out of the balloon for inspection, it was found that electrode 3 had broken and was missing from the lassostar.At this time, the lumen was flushed multiple times with saline to determine if the electrode was in the lumen, small "shards" exited the balloon.Another lassostar was then attempted to be passed through the lumen, but was not able to be passed out the final few centimeters and out the tip.Following that a achieve advance catheter (20mm) was attempted to be passed through the lumen.It also got stuck in the same location.Additional flushing of the lumen was attempted.After additional flushed, the remainder of the electrode exited the lumen of the balloon.At this time, a second afapr028 was used along with the 20mm achieve advance to complete the case.No further incident/issues occurred and the case was completed with cryo.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER, INC.
• MDR Report Key: 17489573
• MDR Text Key: 320721430
• Report Number: MW5122106
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: UNKNOWN
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Patient Sequence Number: 1