MAUDE Adverse Event Report: NUMED, INC. BIB CATHETER; STENT PLACEMENT CATHETER

Model Number	420.1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2022
Type of Reportable Event	Malfunction
Additional 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.Used with a stent but unknown as to mftr, type and size.The complaint catheter was returned in its box and pouch.The catheter is bloody and is in the introducer.The balloon was pushed through the distal end of the introducer.A lateral tear was observed in the outer balloon.The proximal end of the balloon is completely separated from the balloon's distal end.Each section of the balloon is still attached to its respective balloon bond.Microscopic inspection of the balloon showed nothing that would have contributed to the balloon burst.A comparative catheter was pulled and tested for rated burst pressure.The comparative catheter was the same catalog number but a different lot number as the complaint catheter.The balloons were immersed in a body temperature bath and incrementally inflated until they burst.The inner balloon did not burst until 9 atm, which is well above the labeled rbp of 5 atm.The outer balloon did not burst until 7 atm, which is also well above the labeled rated burst pressure of 4 atm.A comparative nucleus-x catheter was also tested.This catheter used the same balloon material as the complaint catheter.The balloon was immersed in a body temperature water bath and inflated until burst.The balloon did not burst until 7 atm, which is well above the labeled rbp of 4 atm.The complaint could not be duplicated with the comparative catheters.It was noted in the report that even though they stated that the balloon "exploded" (burst) at 2 bar, it was further noted after further questioning that they did not use an inflation device with pressure gauge and were not monitoring the pressure when inflating the balloon.Most balloon bursts are caused by over pressurization of the balloon.There is a warning in the instructions for use that states: warning - 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.
Event or Problem Description
As per the report from the user facility / foreign distributor - we have been reporter from the hospital of bern a problem with the reference (b)(4).Apparently the outer balloon exploded at 2 bar, this caused problems in the removal of the balloon.Fortunately the procedure could be terminated without consequences.We are trying to get more information on the incident.

• Brand Name: BIB CATHETER
• Common Device Name: STENT PLACEMENT 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: 15579712
• Report Number: 1318694-2022-00012
• Device Sequence Number: 6470151
• Product Code: NVM
• UDI-Device Identifier: 04046964900174
• UDI-Public: 04046964900174
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K160889
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: 420.1
• Device Catalogue Number: BB017
• Device Lot Number: BIB-11486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2019
• 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 Age: 16 YR
• Patient Sex: Male