MAUDE Adverse Event Report: NUMED, INC. MINI GHOST PTA CATHETER; PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER

Model Number	507
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint catheter was returned in a biohazard bag.There is a longitudinal tear in the balloon.The proximal end of the balloon is attached to the outer tubing.The distal end of the balloon was not returned.The inner tubing is detached.The guidewire was returned with the catheter.The distal 80cm of the guidewire has been cut off.A section of the inner tubing is stretched over this section of the guidewire.A comparative catheter of the same size/catalog number was pulled and tested.The balloon was immersed in a body temperature bath and pressurized in 1 atm increments until the balloon failed.The rated burst pressure for this catalog number is 12 atm.This balloon did not burst until 20 atm, which is well above the labeled rated burst pressure.The balloon burst was caused by the over pressurization of the balloon.According to the report from the user facility, they took this balloon to 24 atm before it burst, which is double the labeled rated burst pressure for this catheter.They were also using this catheter off-label for stent restenosis.This catheter is indicated for angioplasty use only.There are warnings listed in the instructions for use about the over pressurization of the balloons - warnings: "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 reported by the distributor bis and the hospital: "the balloon burst.It is unknown whether an inflation device was used." updated 9/18/2018 - " we ballooned the innominate vein in stent restenosis with the mini ghost to 24 atms, which was used 1 time before to inflate the balloon.The sheath was a 6fr mullins sheath and it was not kinked.The patient had congenital anomalies.After using the mini ghost, we used 6fr and 7fr 75 mustangs.The balloon burst at 24atms.".

• Brand Name: MINI GHOST PTA CATHETER
• Common Device Name: PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• MDR Report Key: 7893140
• Report Number: 1318694-2018-00012
• Device Sequence Number: 18874392
• Product Code: DQY
• UDI-Device Identifier: 04046964341427
• UDI-Public: 04046964341427
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K051343
• 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): 09/20/2018

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: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 507
• Device Catalogue Number: MG150
• Device Lot Number: MG-2509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2018
• Initial Report FDA Received Date: 09/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1