MAUDE Adverse Event Report: PENTAX MEDICAL CRYOBALLOON FOCAL ABLATION SYSTEM; GEN 2 FOCAL STANDARD CATHETER

Model Number FG-1028

Device Problem Pressure Problem (3012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/28/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received at pentax c2 facility for further evaluation on rma (b)(4).On 11-nov-2021, the investigation was completed by c2 r&d and the findings are as follows: a visual inspection was performed on both the controller and catheter which showed no obvious signs of damage.The controller and catheter were functionally tested where a low-pressure fault with an audible and visual fault indicated.Additional catheters were tested with the controller and the system perform as expected.The qa records for this lot (03172021-01) of catheters was reviewed and shows this specific catheter with uid: (b)(4) passed final inspection and left pentax medical with the correct information stored on the catheter.The device log was review showing usage on (b)(6) 2021 with numerous low-pressure faults after initiation a treatment with the foot pedal.The log indicated the delivery valve and exhaust valve were open for the period that would equate to a treatment.This catheter file stored on the controller were examined which shows the initial record of the catheter's data was incorrect, there were several entries in the file that were incorrect.A test was created to compare the encrypted version of qa approved data and the incorrect data.As a result, it was found the rfid chip on the controller misread a block from the catheter rfid tag.The encryption mechanism masked this misread data allowing it to be accepted.Therefore, the general sanity checks of the system were not violated which in turn allowing the system to continue.Since the low balloon pressure was incorrectly set at 22.4 psi due to a bad data block read, every use resulted in a low balloon pressure since the system never operates near that value.Per the instructions for use (ifu - lbl-1016): "if a fault condition occurs, the lcd touch screen on the controller will display an error description with recommended corrective action.If the corrective action displayed does not resolve the fault condition, do not use the system.Contact pentax medical." the user was able to coerce the device to continue and treated with the 10.4 second delivery puff time.As captured in the complaint notes, the doctor continued to perform the procedure despite noting that the "system began to behave abnormally".Although the system alerted the user both visually and audibly that the device was malfunctioning due to the low balloon pressure, these warnings were ignored.The device record was reviewed and the findings are as follows: no issues with the build of these catheters and only issues were known and not associated the s/n (b)(4).Rfid programming was verified as correct and no additional issues found in final inspection.Units rejected - quantity 3 for whipping of hypotube and quantity 6 for pad print flaking.A read error of a data block resulted in incorrect catheter values.The controller produced an audible and visual warning for the user.Instead of discontinuing use per the ifu, the user continued to use the system and completed the treatment to the patient.This failure path has very low chance of reoccurrence as multiple events have to fail in specific ways to allow a similar failure.If additional information becomes available, a supplemental report will be filed with the new information.

Event Description

Pentax medical was made aware of a complaint that occurred in the united states during a gen 2 cryoballoon procedure.The customer reported that while being used with the cryoballoon controller system it began to behave abnormally with a low balloon pressure fault message, but the nitrous would continue to flow involving gen 2 focal standard catheter model fg-1028.There was no report of patient injury, and the doctor successfully ablated the area of concern.

• Brand Name: CRYOBALLOON FOCAL ABLATION SYSTEM
• Type of Device: GEN 2 FOCAL STANDARD CATHETER
• Manufacturer (Section D): PENTAX MEDICAL; 303 convention way; redwood city CA 90463
• Manufacturer (Section G): PENTAX MEDICAL; 303 convention way; redwood city CA 90463
• Manufacturer Contact: william goeller (temporary) ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 12845064
• MDR Text Key: 288031085
• Report Number: 3008780134-2021-00007
• Device Sequence Number: 1
• Product Code: GEH
• UDI-Device Identifier: 00854924006286
• UDI-Public: 00854924006286
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG-1028
• Device Catalogue Number: FG-1028
• Device Lot Number: 03172021-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1