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

Model Number	420.1
Medical Device Problem Codes	Off-Label Use (1494); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2022
Type of Reportable Event	Malfunction
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.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 17 atm, which is well above the labeled rbp of 5 atm.The outer balloon did not burst until 15 atm, which is also well above the labeled rated burst pressure of 9 atm.The bib was being used to expand a palmaz xl stent which is an off label use of this device in the u.S.Since the bib is only indicated for stent placement of the cp stent and g-armor stent.The stent being used is also only approved for biliary applications and it was being used in the rvot, which is another off label use.The palmaz xl device is only rated for a diameter of 10mm.The physician mounted it on this 22mm balloon.The palmaz stent is known to have sharp edges, and with the stent being expanded to more than double its rated size, those sharp edges may have put additional pressure on the balloon when it was being expanded.There were already previous stents as well as a melody valve in place where this additional stent was being expanded.
Event or Problem Description
Balloon rupture.

• 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: 15300016
• Report Number: 1318694-2022-00010
• Device Sequence Number: 2407285
• Product Code: NVM
• UDI-Device Identifier: 04046964900235
• UDI-Public: 04046964900235
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/26/2022

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 Model Number: 420.1
• Device Catalogue Number: BB064
• Device Lot Number: BIB-11960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2020
• 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: 19 YR
• Patient Sex: Male
• Patient Weight: 107 KG