MAUDE Adverse Event Report: NUMED, INC. TYSHAK II CATHETER; PULMONARY VALVULOPLASTY CATHETER

Model Number	105
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The labeled rbp for this device is 3.0 atm.The user facility stated that they over inflated this device at least three times.This over inflation caused the balloon to burst.The comparative catheter was pulled and tested for rbp.The device was taken up to rbp with no issues.It was then over inflated to 4.0 atm at which point the balloon burst.There is a warning in the instructions for use that states: "caution: do not exceed the rbp.An inflation device with pressure gauge is recommended to monitor pressure.Pressure in excess of the rbp can cause balloon rupture and potential inability to withdraw catheter through the introducer sheath.".
Event or Problem Description
As per the incident report from bis: "balloon inflated otw to the pulmonic valve.Inflated at 3.5 atm for 15 seconds, inflated at 3.5 atm for 10 seconds, inflated at 2.0 atm for 10 seconds.Balloon ruptured.Removed balloon otw, could not get the balloon through the sheath, removed all together.Unsure if all of the balloon was removed from the body." a follow-up report was also sent to numed from bis with this additional information: "in a conversation the bis sales specialist had with the account: the physician was using the balloon for pulmonic valvuloplasty.An inflation device with pressure gauge was used - merit digital inflator.A st.Jude fast track 8 fr introducer was used.The catheter shaft was not kinked.There was nothing unusual about the patient anatomy.Their (sic) was no change in the patient condition post procedure.No second balloon was used to complete the procedure.The balloon burst at 3.5 atms.".

• Brand Name: TYSHAK II CATHETER
• Common Device Name: PULMONARY VALVULOPLASTY CATHETER
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• MDR Report Key: 6311772
• Report Number: 1318694-2017-00005
• Device Sequence Number: 13655757
• Product Code: DQY
• UDI-Device Identifier: 04046964338847
• UDI-Public: 04046964338847
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K003052
• 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
• Report Date (Section B): 02/08/2017

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 09/30/2021
• Device Model Number: 105
• Device Catalogue Number: PDC511
• Device Lot Number: TT-12160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2017
• Initial Report FDA Received Date: 02/08/2017
• 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