MAUDE Adverse Event Report: NUMED, INC. Z-5 ATRIOSEPTOSTOMY CATHETER

Model Number	210
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	03/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Reported to numed as a balloon pin hole from the user facility / distributor.A medwatch that was received from the fda reports it as a balloon burst.
Additional Manufacturer Narrative
Device was not returned so the complaint could not be confirmed.Complaint problem could not be fully identified due to it being reported as a pinhole leak by the user facility / distributor and then reported by user facility on the medwatch form as a balloon burst.User facility report number is mw5107883.Distributor report from user facility has two devices having issues, however the medwatch report only has the one.Additional information was requested, but was not provided.A review of the device history record was performed and no issues were found.All devices within the lot met all requirements for release and distribution.There have been no other complaints associated with this lot number.A review of the balloon material used shows there are no other complaints associated with the balloon material used to manufacture the balloons used on this lot of catheters.A comparative device was pulled and tested.The same catalog number as the complaint device, but a different lot number.This device used the same balloon raw material and balloon tubing as the complaint catheter.The catheter was inflated and the balloon burst at 2.7ml (cc), which is well above the labeled rated volume of 2.0cc (ml).There were no leaks found prior to the balloon bursting.All devices are leak tested at final qc before being released for distribution.It was reported that the issues with the patient may have been caused by air in the patient's system.If the instructions for use were followed, air should not have been introduced into the patient's system even with a balloon leak or burst.The following statements are from the instructions for use: warning: use only appropriate balloon inflation medium.Do not use air or gaseous medium to inflate the balloon.Inspection and preparation: purge and flush the catheter through lumen thoroughly, observing for leaks.Point inflation device with pressure gauge nozzle downward, aspirate until all air is removed from the balloon, and bubbles no longer appear in the contrast medium.Following the steps outlined in the ifu, any leaks should have been noticed prior to use on the patient.It is unknown as to the patient's age, the volume used in this balloon during that procedure, and any other patient condition that may have affected this adverse event/malfunction.All of these things could be a factor with either of the issues that has been reported.Additional information has repeatedly been requested but not provided.

• Brand Name: Z-5 ATRIOSEPTOSTOMY CATHETER
• Common Device Name: SEPTOSTOMY 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: 13937686
• Report Number: 1318694-2022-00003
• Device Sequence Number: 17759329
• Product Code: DXF
• UDI-Device Identifier: 04046964333439
• UDI-Public: 04046964333439
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K960070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: 210
• Device Catalogue Number: SPT003
• Device Lot Number: AC-1109
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown