MAUDE Adverse Event Report: NUMED, INC. PTS; PERCUTANEOUS TRANSLUMINAL SIZING CATHETER

Model Number	360
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A comparative catheter was pulled and tested for rbp.The device was taken up to rbp (1 atm) with no issues.It was then over inflated to 1.5 atm at which point the balloon burst longitudinally.Numed can not confirm if an inflation device with pressure gauge was used, or what pressure the balloon was inflated to, due to lack of information.An inflation device with pressure gauge is recommended per the instructions for use.Numed can not confirm this complaint.Device not returned.
Event or Problem Description
As per hospital medwatch report: "a male patient with history of bicuspid aortic valve disease status post ross procedure with resulting stenotic pulmonary homograft admitted for transcatheter pulmonary valve replacement.Balloon sizing of the pulmonary artery with dyna ct performed with a 30 mm x 5 cm numed percutaneous transluminal sizing (pts) sizing balloon.Balloon was advanced into the right ventricular outflow tract (rvot) and main pulmonary artery and inflated under rapid pacing.The balloon ruptured at low pressure requiring removal of 16f sheath and replacement with a 16f short cook sheath and the balloon was successfully retrieved.The procedure was aborted and rescheduled." addition information per distributor: "it is unknown whether an inflation device with pressure gauge was used.The catheter shaft was kinked.There was nothing unusual about the patient anatomy.The patient was stable post procedure.The balloon ruptured circumferentially, it is unknown at what atm the balloon ruptured - the report states only 'at low pressure'.".

• Brand Name: PTS
• Common Device Name: PERCUTANEOUS TRANSLUMINAL SIZING CATHETER
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• MDR Report Key: 6604958
• Report Number: 1318694-2017-00014
• Device Sequence Number: 91996
• Product Code: MJN
• UDI-Device Identifier: 04046964310997
• UDI-Public: 04046964310997
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K003320
• 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): 06/01/2017

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 Expiration Date: 12/31/2021
• Device Model Number: 360
• Device Catalogue Number: PTS305
• Device Lot Number: OS-1739
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2017
• Initial Report FDA Received Date: 06/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 154