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

Model Number	420.1
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was received and a balloon burst was confirmed.There is a circumferential tear in the balloon.The distal end of the balloon is detached.The inner and middle tubing have been stretched so that 13cm are protruding from the distal end of the outer tubing.The proximal image band is under the proximal balloon stem.The spacing of the inner image bands is 2.9cm.The spacing for the outer image bands is 3.9cm.The image band spacing was within specification.The proximal location of the bands most likely occurred when the middle tubing was stretched.The production records were reviewed and no issues were noted.All devices distributed from this lot met all of the requirements for release.There have been no other complaints associated with this lot of devices.A review of the balloon tubing used to manufacture the balloons used on this lot of devices was performed.There are no other complaints associated with this balloon tubing lot number.A reject device from a different lot was pulled and tested for rated burst pressure.This reject device used the same balloon material lot number as the complaint device for the outer balloon.The catheter had been rejected for image band placement.A guidewire was inserted, and then the balloons were inflated until failure.The inner balloon ruptured at 12 atm, which is well above the labeled rated burst pressure of 4.5 atm.The outer balloon ruptured at 7 atm, which is also well above the labeled rated burst pressure of 3 atm.This was an off-label use.The indications for use with this device is specific to the cp stent for stent placement.The palmaz stent is known to have very sharp edges.By trying to flare the palmaz stent with the bib catheter, it is most likely that the sharp edges of the palmaz stent caused the balloon to burst.
Event or Problem Description
Bib used in melody valve case.Covered mounted cp stent (cmcp033) deployed.2 pal maz deployed within the cp.Used bib# 614445 to flare the edge of the stent.Bib ruptured circumferentially inside patient.Required cardiac surgical cut down to get everything out safely and then finished valve implant.The inner balloon was inflated before the outer balloon.The catheter shaft was not kinked.A presto inflation device was used.The introducer sheath was a 22 fr dry seal.Patient has a truncus type 2 cardiac anatomy.Post procedure patient condition: patient fully recovered with incision that was not necessary.Additional information received on 1/26/2021 - the bib that ruptured was used to deploy the second of the pal maz stents and it was used to flare the proximal end of the stent immediately after deployment.Also the balloon markers on the bib that ruptured were off - account mounted the stent at the locations of the balloon markers hoover upon inflation of the balloon it was clear that the stent was not centered on the balloon.Account implanted the covered cp stent initially followed by 2 separate pal maz stents to further reinforce the radial strength of the stented outflow tract.

• Brand Name: BIB STENT PLACEMENT CATHETER
• Common Device Name: STENT PLACEMENT CATHETER
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• MDR Report Key: 11327328
• Report Number: 1318694-2021-00001
• Device Sequence Number: 16422081
• Product Code: NVM
• UDI-Device Identifier: 04046964900228
• UDI-Public: 04046964900228
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/15/2021

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: 07/31/2025
• Device Model Number: 420.1
• Device Catalogue Number: BB063
• Device Lot Number: BIB-11857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 02/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 19 YR
• Patient Weight: 103