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

Model Number	210
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As per the report received from the distributor bis, "upon pull back the balloon and marker band detached from the catheter and embolized to the left subclavian artery.".
Additional Manufacturer Narrative
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.The device was being used in a patient that was just over 6 weeks old.There is a precaution in the ifu that states: "balloon atrioseptostomy should not be performed for infants older than six weeks.These infants will have thick atrial septums.Reference aha/acc guidelines." this patient was over 6 weeks old and balloon atrioseptostomy should not have attempted according to the aha/acc guidelines.There is also a warning that states: "the use of excessive force to pull the balloon across the atrial septum must be avoided." additional instructions are also provided in the instructions for use to avoid the use of excessive force.It states "the use of excessive force to pull the balloon across the atrial septum must be avoided.Specifically, the physician should avoid using the entire arm when pulling the balloon across the septum and should instead use only the motion of the wrist.If the balloon does not easily cross the septum using this method, it is recommended that a smaller volume of fluid be used initially.The amount of fluid can then be gradually increased in volume until the desired result is achieved.If the first two steps are not successful, consider static balloon dilation of the atrial septum." this was the fourth pull back performed during this procedure.The first three pull backs were performed with a different device.The fourth pull back was with this mdr device.Potential balloon separation with subsequent need of snare is a known complication of this procedure and is listed as a potential complication in the instructions for use.The catheter was returned to numed for review.The balloon was detached at the distal portion of the proximal balloon bond.There is 4mm of balloon stem bonded to the catheter shaft.The balloon, alond with the distal end of the shaft and image band are missing.The shaft is detached 1mm distal to the inflation hole.A comparative catheter was tested.This catheter was the same catalog number, but a different lot number.The catheter's proximal balloon bond and balloon to tip bond were both pull tested on a calibrated instron machine.The pull strength of the proximal balloon bond was 7.23 lbf (32.16 n) and the pull strength of the balloon to tip junction was 7.38 lbf (32.83 n).The in vitro bench testing for this device was reviewed.Acceptance criteria for the in vitro bench testing was 2.0 lbf (8.9 n).The average bench testing results for the two bond sites tested were: proximal balloon bond - 5.8 lbf (25.8 n) and balloon to tip - 3.71 lbf (16.5 n).The comparative bond strengths were well above the acceptance criteria and the averages found during the testing.It is likely that the patient's age contributed to the failure of the complaint catheter.

• 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: 16387696
• Report Number: 1318694-2023-00002
• Device Sequence Number: 20105554
• Product Code: DXF
• UDI-Device Identifier: 04046964333439
• UDI-Public: 04046964333439
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/16/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Model Number: 210
• Device Catalogue Number: SPT003
• Device Lot Number: AC-1111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 6 WK
• Patient Sex: Unknown