MAUDE Adverse Event Report: NUMED, INC. Z-MED II-X CATHETER; PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER

Model Number	305X
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	06/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As per the report from the user facility / distributor - post procedure the deflated balloon would not withdraw into the 9f cordis avanti sheath.Dr tried to remove sheath and balloon together but felt resistance and stopped.Vascular surgeon performed a femoral cut down and removed the sheath and balloon.Patient was stable post procedure.
Additional Manufacturer Narrative
The catheter was returned in a biohazard bag.The catheter is bloody.The proximal portion of the catheter including the extension has been cut off and not returned.The distal 5mm of the balloon is bunched up where it caught in the introducer.Contrast media can be seen in the distal portion of the balloon.The distal portion of the outer catheter shaft is stretched down on to the braided inner tubing.A comparative catheter of the same catalog number/size (pdz730, lot# zzx-3923) was tested.A guidewire was inserted through the catheter, the catheter was then inserted through a 9fr introducer.The balloon was inflated to the labeled rated nominal pressure of 4.0 atm and then fully deflated.Upon deflation the catheter was then removed from the 9fr introducer.No issues were found with the comparative catheter.The problem could not be reproduced when the instructions were followed.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.Previous experience has shown that complaints of this type are typically due to the balloon not being completely deflated before being pulled back into the introducer sheath.When this happens the contrast media that is left in the balloon is pushed into the distal portion of the balloon and then catches on the tip of the introducer sheath.Once that distal portion is caught on the introducer, any additional pulling force on the catheter shaft will cause it to stretch.The catheter was being used for aortic valvuloplasty, which is an off-label use for this catheter.An inflation device with pressure gauge was not used as is recommended in the instructions for use.The comparative catheter was tested and was introduced through, and removed from, the labeled rated 9fr sheath size.All numed balloon catheters are tested for their rated introducer size in final inspection before the product is released for distribution.

• Brand Name: Z-MED II-X CATHETER
• Common Device Name: PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY 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: 15029351
• Report Number: 1318694-2022-00007
• Device Sequence Number: 6214798
• Product Code: DQY
• UDI-Device Identifier: 04046964315787
• UDI-Public: 04046964315787
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K022722
• 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): 07/15/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 305X
• Device Catalogue Number: PDZ730
• Device Lot Number: ZZX-3939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2022
• Initial Report FDA Received Date: 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2021
• 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: 68 YR
• Patient Sex: Male