MAUDE Adverse Event Report: NUMED, INC. Z-MED II CATHETER; AORTIC VALVULOPLASTY CATHETER

Model Number 305.1

Device Problem Material Rupture (1546)

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

Event Date 02/29/2024

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record was performed and no issues were noted.There are no other complaints associated with this lot number of devices.A review was also performed on the balloon tubing used to manufacture these balloons.No other complaints were associated with the tubing used to manufacture the balloons.Review of data from user facility shows that the device was inflated once within the patient, however, the balloon was not positioned correctly.It is unknown as to what pressure the balloon was taken to when inflated the first time.It was noted in the report that the valve was heavily calcified.Then when a second dilatation was performed, it was noted that the balloon was taken to almost double the labeled rated burst pressure before rupturing.Labeled rated burst pressure for this device is 4 atm and the device was taken to 8 bar according to the user facility.Over pressurization of balloons will cause the balloon to rupture, as noted in the instructions for use.The following warning is listed in the ifu - "caution: do not exceed the rbp.An inflation device with pressure gauge is recommended to monitor pressure.Pressure in excess of the rbp can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath." there is also a note in the potential complications section advising the physician on what to do when a rupture happens - "note: there have been infrequent reports of larger diameter balloons bursting circumferentially, possibly due to a combination of tight focal strictures in large vessels.In any instance of a balloon rupture while in use, it is recommended that a sheath be placed over the ruptured balloon prior to withdrawal through the entry site.This can be accomplished by cutting off the proximal end of the catheter and slipping an appropriately sized sheath over the catheter into the entry site." the physician followed this, but only after trying to remove the ruptured balloon back into the sheath and causing the balloon tip to tear off and get stuck on the guidewire.A comparative catheter was pulled and tested.The device was the same catalog number but from a different lot number.The tubing used to manufacture the balloon was the same lot number for both the complaint catheter as well as the comparative catheter.The balloon was immersed in a body temperature water bath and inflated until it failed.The comparative catheter balloon did not burst until 9.0 atm, which is well above the labeled rated balloon burst of 4.0 atm.Over pressurization caused the balloon to burst.

Event Description

As per the report from the user facility / foreign distributor - balloon burst intraoperatively, tip ruptured during retraction and got caught on the safari wire.Additional information was provided from the user facility / foreign distributor: the valve was very calcified.During the first dilatation attempt, the balloon was placed too high, requiring a second attempt.During this second dilation the balloon ruptured.The wire used for the procedure was cook's safari xs, and the introducer was a 14f.The broken tip remained inside the sheath, and during the removal attempt, this tip got stuck on the wire.The outer filament of the safari was also damaged.It was necessary to cut both the wire and the balloon and put a sheath back on.The broken balloon could be completely removed.No consequences for the patient.

• Brand Name: Z-MED II CATHETER
• Type of Device: AORTIC VALVULOPLASTY CATHETER
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• Manufacturer (Section G): NUMED, INC.; 2880 main street; hopkinton NY 12965
• Manufacturer Contact: nichelle laflesh ; 2880 main street; hopkinton, NY 12965 ; 3153284491
• MDR Report Key: 18978938
• MDR Text Key: 338628514
• Report Number: 1318694-2024-00003
• Device Sequence Number: 1
• Product Code: OZT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K122012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 305.1
• Device Catalogue Number: PDZ661
• Device Lot Number: ZZ-14020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2024
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2022
• 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: 88 YR
• Patient Sex: Female
• Patient Weight: 68 KG