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

Model Number	305X
Medical Device Problem Codes	Off-Label Use (1494); Difficult to Remove (1528)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint catheter was not returned, so analysis of the device is not possible.The catheter was being used for atrial septum ballooning, which is an off-label use for this catheter.A comparative catheter, of the same catalog number, was tested.This catheter was a pdz716, lot # zzx-3284.The balloon was passed through an 8f introducer and inflated to rbp in a body temperature water bath.The balloon was then deflated and pulled back through the introducer.The catheter easily passed through the introducer in both directions.Zzx catheters are passed through the recommended introducer size during final inspection.These sizes are established during the bench testing process.In addition, an 8f balloon protector was placed over the balloon of each catheter without issue.Each device is provided with an ifu, which states the following: precaution (#6): before removing the catheter from the sheath it is very important that the balloon is completely deflated.Instruction (#8): deflate the balloon by drawing a vacuum with an inflation device with pressure gauge.Note: the greater the vacuum applied and held during withdrawal, the lower the deflated balloon profile.Gently withdraw the catheter.As the balloon exits the vessel, use a smooth, gentle, steady motion.If resistance is felt upon removal, then the balloon, guidewire and the sheath should be removed together as a unit under fluoroscopic guidance, particularly if balloon rupture or leakage is known or suspected.This may be accomplished by firmly grasping the balloon catheter and sheath as a unit and withdrawing both together, using a gentle twisting motion combined with traction.The production traveler (dhr) was reviewed and no issues were found.All devices in this lot met the criteria for release and distribution.There are no other associated complaints with this lot of devices.A review was performed on the component lots used for the manufacturing of this lot of devices.There were no other associated complaints with the components used.
Event or Problem Description
The balloon would not enter the sheath post inflation.Balloon was surgically removed.The balloon was being used for atrial septum ballooning.An inflation device with pressure gauge was used.A cook flexor 10fr introducer sheath was used.The catheter shaft was not kinked.There was nothing unusual about the patient anatomy.(b)(6) 2021 - in an email from the account - items used with the balloon:.035 superstiff wire,.035 j wire, 10fr flexor cook, 12fr flexor sheath, 16fr cook sheath.

• 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
• MDR Report Key: 12328175
• Report Number: 1318694-2021-00007
• Device Sequence Number: 4542834
• Product Code: DQY
• UDI-Device Identifier: 04046964315497
• UDI-Public: 04046964315497
• 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: distributor,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2021

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: 03/31/2025
• Device Model Number: 305X
• Device Catalogue Number: PDZ716
• Device Lot Number: ZZX-3570
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 08/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 12 YR
• Patient Weight: 37