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

Model Number	302
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint catheter was not returned, so further analysis of that device is not possible.A comparative catheter was pulled and tested for rated burst pressure.The labeled rated burst pressure for this device is 4 atm.The comparative catheter was taken to rbp and did not burst.It was inflated until it did burst, and that was not until 7 atm.The complaint states that the balloon was being used for severe as.It is possible that the nature of the stenosis played a role in the balloon burst.According to the report, the balloon burst right at labeled rbp.Not returned to manufacturer.
Event or Problem Description
As per the report from (b)(6): "while doing a valvuloplasty, the balloon burst in the patient body.The balloon was being used for severe as.An inflation device with pressure gauge was used.A 9fr introducer sheath was used.The catheter shaft was not kinked.There was nothing unusual about the patient anatomy.Patient was fine post procedure.A second balloon was not used.The balloon ruptured circumferentially at 4 atm.".
Additional Manufacturer Narrative
The complaint catheter was not returned, so further analysis of that device is not possible.A comparative catheter was pulled and tested for rated burst pressure.The labeled rated burst pressure for this device is 4 atm.The comparative catheter was taken to rbp and did not burst.It was inflated until it did burst, and that was not until 7 atm.The complaint states that the balloon was being used for severe as.It is possible that the nature of the stenosis played a role in the balloon burst.According to the report, the balloon burst right at labeled rbp.Follow up 001 - updated to correct the 510(k) number referenced.
Event or Problem Description
As per the report from bis: "while doing a valvuloplasty, the balloon burst in the patient body.The balloon was being used for severe as.An inflation device with pressure gauge was used.A 9fr introducer sheath was used.The catheter shaft was not kinked.There was nothing unusual about the patient anatomy.Patient was fine post procedure.A second balloon was not used.The balloon ruptured circumferentially at 4 atm.".

• Brand Name: Z-MED CATHETER
• Common Device Name: VALVULOPLASTY CATHETER
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• MDR Report Key: 6347217
• Report Number: 1318694-2017-00007
• Device Sequence Number: 13828743
• Product Code: OZT
• UDI-Device Identifier: 04046964329463
• UDI-Public: 04046964329463
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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,user facility
• Initial Reporter Occupation: Other
• 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: 09/30/2021
• Device Model Number: 302
• Device Catalogue Number: PDZ347
• Device Lot Number: Z-7124
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/01/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2017
• 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