MAUDE Adverse Event Report: PENTAX OF AMERICAS, INC. CRYOBALLOON ABLATION SYSTEM; GEN 2 CONTROLLER

Model Number FG-1017

Device Problem Gas Output Problem (1266)

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

Event Date 03/01/2022

Event Type  malfunction  

Event Description

It was reported that the fg-1017- cryoballoon controller was malfunctioning.The physician was reportedly preparing to perform a cryoballoon ablation, when on his initial inflation attempt a puff was heard in the controller, the balloon would not inflate and fault screen appeared asking if the catheter was properly attached.They tried to trouble shoot this, but the issue would not go away.They tried multiple catheters and cartridges and could not resolve the problem.The physician moved to treat the patient with alternative therapy options and alerted the pentax medical sales rep to the issue.No serious injury or death of a patient or user, or delay in the procedure which would require medical intervention was reported by the user.Once returned, the controller will be evaluated as part of the investigation.This event meets the requirements for fda reportability; however submission of this report does not constitute an admission that medical personnel, user facility, importer, manufacturer or product caused or contributed to the event.

Manufacturer Narrative

(b)(4).The pentax medical sales rep went into the facility the following day to pick up the complaint controller.A field inspection of the complaint controller revealed the u-shaped locking pin for the connector plug was not visible as it should be.An absence of this locking pin would result in the problem the user was observing during the out of box initial usage.The sales rep believes the locking pin slipped out of position and is still somewhere inside the controller.Incomplete attachment of the catheter locking into the controller into the "home position" could result in potential ejection of the catheter and injuries to the user or patient.The complaint investigation is in-process.

Manufacturer Narrative

Updated.B4: date of report.B5: refer to h10.G6: followup 01 report selected.H6.Type of investigation: added: 10 testing of actual/suspected device, removed: 4114 device not returned, 4118 type of investigation not yet determined investigation findings: added: 180 mechanical problem identified, removed: 3233 results pending completion of investigation conclusions: added: 4315 cause not established, removed: 11 conclusion not yet available.H10: the fg-1017 controller, serial number (b)(6), lot number 06082021-07 was returned and evaluated.The investigation was completed on 28-jun-2022.Fg-1024-07202021-02, serial number (b)(6) was returned and evaluated.Fg-1028-11232021-01 was returned but the traceability was lost once returned within operations processing.Based on the information provided, the complaint mentions the balloon not being able to inflate from an initial inflation attempt.Some reasons for the balloon to not inflate are kinks on the catheters, causing occlusions or the catheter not properly connected to the controller.Since the user also received a fault screen asking if the catheter was properly connected, this investigation will focus on the controller and the components which connect to the catheter.Device log files were recovered from controller (b)(6) balloon psi measurements were reviewed for fg-1028 (l/n : 11232021-01) and fg-1024 (l/n: 07202021-02).Based on the log files, in both catheters (fg-1028 and fg-1024), the balloon was not able to reach and maintain a suitable psi for the user to perform a treatment.The controller (b)(6) did not show any signs of damage on the exterior surface and when tilting the controller, there was no sound of loose metallic components inside the housing.However, when looking into the section where the catheter is inserted into the controller, it was notice that the sliding locking pin (prt-1780) was not visible.Controller (b)(6) was functionally tested with r&d catheter (l/n: 10162020-08) and foot pedal(b)(6).When the catheter was inserted into the controller, the controller accepted it and prompted the user to insert a nitrous cartridge.Once the cartridge was inserted the controller screen changed to the treatment menu.In this, the controller was working as deigned and performing as intended.After pressing on the treatment switch of the foot pedal, the controller could not inflate the balloon and the following prompt "improper catheter attachment.Please reattempt attachment" was displayed, followed by an "insufficient n2o flow" error on the controller screen.The log files are similar to fg-1028 (l/n: 1123202101) and fg-1024 (l/n: 07202021-02), in that the balloon pressure did not reach and maintain a certain amount in order to perform a treatment.On 12-aug-2022, a lot history record(dhr) review was completed by the manufacturer for fg-1017 controller, serial number (b)(6), lot number 06082021-07, fg-1028 catheter, lot number 1123202101(expiration date 14-dec-2023), and fg-1024 catheter, lot number 07202021-02(expiration date 17-aug-2023).The review confirmed the devices were manufactured under normal conditions, passed all required inspections, and were released accordingly.No reworks or concessions were noted.The housing of the returned controller was opened, and it was noticed that the sliding locking pin (prt-1780), used for connecting the universal catheter connector plug (prt-1743) to the traversing member main (prt-1730) of the controller, was bent and had fallen out of its normal position and was unsecured within the body of the controller, except as stuck in place by sticky-tape used for wire retention.The locking pin serves to hold the delivery line in connection with the controller's traversing member, by fitting within the grooves of the catheter connector plug.Under normal operation, the locking pin moves up and down.At its highest position, the locking pin is still retained by the assembly.To remove, the pin would require being pulled out with sufficient force to temporarily straighten its angled legs.As a result of the locking pin falling out of place, the catheter was not able to be properly connected and retained to the controller's traverse member and delivery line (prt-1324).This prevents n2o from flowing through the catheter, causing the balloon to be unable to inflate.Upon further examination, the bracket, lock handle connector (prt-1734) appears to present with some minor damage, and the high pressure pcba (prt-2366) appears to present with possible minor damage.These damages are cosmetic in nature, as they do not affect the component's ability to work as designed and preform as intended.However, they may present with clues as to how the locking pin may have been moved from its normal location.Using the provided controller , the problem was reproduced from the investigation.During the disassembly and interior inspection, it was found that the sliding locking pin which connects the catheter's connector plug to the controller's traverse member had fallen out or been knocked out.The cause for this is unknown, though a probable chain of events preceding the dislodgement is hypothesized.In all other aspects, the controller was found working as designed and performing as intended.The replacement controller, model fg-1017, was shipped under sales order number 1284825, delivery number 8403654.Replacements were not provided for the catheters which were not returned.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.

• Brand Name: CRYOBALLOON ABLATION SYSTEM
• Type of Device: GEN 2 CONTROLLER
• Manufacturer (Section D): PENTAX OF AMERICAS, INC.; 303 convention way; redwood city CA 90463
• Manufacturer (Section G): PENTAX OF AMERICAS, INC.; 303 convention way; redwood city CA 90463
• Manufacturer Contact: william goeller ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 13969405
• MDR Text Key: 298227230
• Report Number: 3008780134-2022-00001
• Device Sequence Number: 1
• Product Code: GEH
• UDI-Device Identifier: 00854924006170
• UDI-Public: 00854924006170
• 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,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG-1017
• Device Catalogue Number: FG-1017
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1