BIB CATHETER 420.1 BB062

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-24 for BIB CATHETER 420.1 BB062 manufactured by Numed, Inc..

Event Text Entries

[115064751] 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.
Patient Sequence No: 1, Text Type: N, H10


[115064752] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1318694-2018-00008
MDR Report Key7713510
Date Received2018-07-24
Date of Report2018-07-24
Date of Event2018-06-26
Date Mfgr Received2018-07-03
Device Manufacturer Date2017-04-25
Date Added to Maude2018-07-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. MELISSA THOMAS
Manufacturer Street2880 MAIN STREET
Manufacturer CityHOPKINTON NY 12965
Manufacturer CountryUS
Manufacturer Postal12965
Manufacturer Phone3153284491
Manufacturer G1NUMED, INC.
Manufacturer Street2880 MAIN STREET
Manufacturer CityHOPKINTON NY 12965
Manufacturer CountryUS
Manufacturer Postal Code12965
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameBIB CATHETER
Generic NameSTENT PLACEMENT CATHETER
Product CodeNVM
Date Received2018-07-24
Returned To Mfg2018-07-17
Model Number420.1
Catalog NumberBB062
Lot NumberBIB-9161
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerNUMED, INC.
Manufacturer Address2880 MAIN STREET HOPKINTON NY 12965 US 12965


Patients

Patient NumberTreatmentOutcomeDate
10 2018-07-24

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