MAUDE Adverse Event Report: NUMED, INC. BIB CATHETER; STENT PLACEMENT CATHETER

Model Number	420.1
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was being used off label for an unapproved indication.This catheter is only indicated for stent placement.This device was being used for main pulmonary artery valvuloplasty.A comparative catheter from the same lot was pulled and tested for rated burst pressure.The labeled rbp for this device is 3 atm.The comparative catheter was immersed in a body temperature bath and inflated 40 times to 3 atms.The balloon was then inflated in 1 atm intervals, starting at 4 atms, until failure occured at 7 atms, which is more than double the labeled rbp.
Event or Problem Description
The product performed well and did its job, but after inflating for the last time it ruptured.The balloon ruptured longitudinally at 3 atm.The indication the physician was using the balloon for: main pulmonary artery valvuloplasty.An inflation device with pressure gauge used.A 12 f cook introducer sheath was used.The catheter shaft was not kinked.There was nothing unusual about the patient anatomy.The patient was ok post procedure.A second balloon was not needed to complete the procedure.

• Brand Name: BIB CATHETER
• Common Device Name: STENT PLACEMENT CATHETER
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• MDR Report Key: 7713510
• Report Number: 1318694-2018-00008
• Device Sequence Number: 13719573
• Product Code: NVM
• UDI-Device Identifier: 04046964900211
• UDI-Public: 04046964900211
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K160889
• 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): 07/24/2018

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: 05/31/2022
• Device Model Number: 420.1
• Device Catalogue Number: BB062
• Device Lot Number: BIB-9161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1