MAUDE Adverse Event Report: NUMED, INC. PTS-X CATHETER; SIZING BALLOON

Model Number	360X
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The balloon burst was confirmed.A comparative catheter was tested for rated burst pressure.The labeled rbp for this catheter is 1.0 atm.The comparative catheter was taken to 2.0 atm before it burst.The user facility stated that they did not use an inflation device with pressure gauge to inflate this balloon as is recommended in the instructions for use.Due to them not using an inflation device with pressure gauge, it is unknown as to what pressure they took this balloon too.A syringe was used to inflate the balloon, so it is likely that the balloon burst due to over inflation.
Event or Problem Description
As per the report from bis: "while inflating the balloon at the maximum size, the balloon ruptured.It ruptured at the rated burst pressure.Account then went to a bigger sized balloon.A ptsx404 was used to complete the procedure.No harm to the patient.The catheter shaft was not kinked.There was nothing unusual about the patient anatomy." a later follow-up stated: "in an email from the account: they were using the balloon for vessel sizing.An inflation device with pressure gauge was not used, they used a 60cc syringe.No patient information will be provided.".

• Brand Name: PTS-X CATHETER
• Common Device Name: SIZING BALLOON
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• MDR Report Key: 6412700
• Report Number: 1318694-2017-00009
• Device Sequence Number: 13728683
• Product Code: MJN
• UDI-Device Identifier: 04046964512094
• UDI-Public: 04046964512094
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K041306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date (Section B): 03/16/2017

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: 08/31/2021
• Device Model Number: 360X
• Device Catalogue Number: PTSX304
• Device Lot Number: OSX-0418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2017
• Initial Report FDA Received Date: 03/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1