MAUDE Adverse Event Report: NUMED, INC. TYSHAK II PTV CATHETER; PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER

Model Number	105
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Catheter was received and a visual inspection was performed.The balloon burst was confirmed.It burst circumferentially and all pieces are accounted for.In the report it states that the balloon burst at 3-4 atm.The labeled rbp for this catheter is 2 atm.Over pressurization of the balloon can cause a balloon burst.This device was also being used off label for a bioprosthetic valve.A comparative catheter of the same catalog number was pulled and tested for rbp.The catheter was taken to the labeled rbp of 2 atm with no issues.It was then inflated until failure, which occurred at 3.5 atm.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 the catheter through the introducer sheath.".
Event or Problem Description
As per the report from bis - "case was a pulmonary artery angioplasty and the balloon ruptured longitudinally in the pulmonary artery.Physician was able to snare and remove the fragmented piece left behind.Patient is fine." on (b)(6) 2017 update - "in an email from the account: an inflation device with pressure gauge was used.The balloon burst at about 3-4 atm.The shaft was not kinked.A 0.025 super stiff guidewire was used.A vida balloon was used to complete the procedure.Regarding the patient anatomy the account noted: yes, it was unusual as the tyshak ii was used on a bioprosthetic valve.".

• Brand Name: TYSHAK II PTV CATHETER
• Common Device Name: PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• MDR Report Key: 6771781
• Report Number: 1318694-2017-00021
• Device Sequence Number: 13857022
• Product Code: LIT
• UDI-Device Identifier: 04046964339257
• UDI-Public: 04046964339257
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/07/2017

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: 02/28/2022
• Device Model Number: 105
• Device Catalogue Number: PDC532
• Device Lot Number: TT-12503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2017
• Initial Report FDA Received Date: 08/07/2017
• 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: Required Intervention
• Patient Age: 6 YR
• Patient Weight: 37