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

Model Number	107
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device was not returned to numed for investigation.The original user facility medwatch report provided only minimal information.The user facility was contacted and was unable to provide any additional information.Since the lot number is not known, the manufacture date and expiration date can't be confirmed.This device was not used on a patient.A sample catheter of the same catalog number was pulled and tested for inflation/deflation specifications.The balloon was immersed in a body temperature water bath and inflated to rated burst pressure of 4 atm.A vacuum was then drawn on the catheter.The time until total deflation was measured.The catheter reached full deflation in 7 seconds, which is well below the 10 seconds specification for deflation time for this catalog number.
Event or Problem Description
As per the medwatch report received from the fda - "while prepping the balloon, the balloon would not deflate completely.A new balloon was obtained and procedure was completed.Original device was not used on patient.Reportedly, there was no harm to patient.".

• Brand Name: TYSHAK MINI
• Common Device Name: PEDIATRIC PULMONARY VALVULOPLASTY CATHETER
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• MDR Report Key: 6976383
• Report Number: 1318694-2017-00027
• Device Sequence Number: 1228463
• Product Code: DQY
• UDI-Device Identifier: 04046964339714
• UDI-Public: 04046964339714
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K003276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other,user facili
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/25/2017

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: Physician
• Device Model Number: 107
• Device Catalogue Number: PDC404
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 10/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 9 DA
• Patient Weight: 2