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

Model Number	305
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Balloon burst was confirmed, however, numed has not been able to get any additional information from this facility.It is unknown as to the indication it was being used for, the pressure it was taken, and if an inflation device with pressure gauge was used as is recommended in the instructions for use.No conclusion can be drawn about this device.The reserve sample that was pulled and tested for rbp passed specification.The labeled balloon rbp is 3.5 atm.The reserve sample was inflated until it failed.It did not burst until 7 atm, which is double the labeled rbp.
Event or Problem Description
As per the report from bis - "balloon burst circumferentially.".
Additional Manufacturer Narrative
Balloon burst was confirmed, however, numed has not been able to get any additional information from this facility.It is unknown as to the indication it was being used for, the pressure it was taken, and if an inflation device with pressure gauge was used as is recommended in the instructions for use.No conclusion can be drawn about this device.The reserve sample that was pulled and tested for rbp passed specification.The labeled balloon rbp is 3.5 atm.The reserve sample was inflated until it failed.It did not burst until 7 atm, which is double the labeled rbp.Follow-up 001 - updated 2/22/2017 to correct 510(k) number in the report.
Event or Problem Description
As per the report from bis - "balloon burst circumferentially.".

• Brand Name: Z-MED II
• Common Device Name: AORTIC VALVULOPLASTY CATHETER
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• MDR Report Key: 6292177
• Report Number: 1318694-2017-00003
• Device Sequence Number: 603634
• Product Code: OZT
• UDI-Device Identifier: 04046964335815
• UDI-Public: 04046964335815
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K122012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2017

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: No Information
• Device Expiration Date: 09/30/2019
• Device Model Number: 305
• Device Catalogue Number: SO071
• Device Lot Number: ZZ-6869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/06/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/01/2017
• Supplement Report FDA Received Date: 02/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1