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..
[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
Report Number | 1318694-2018-00008 |
MDR Report Key | 7713510 |
Date Received | 2018-07-24 |
Date of Report | 2018-07-24 |
Date of Event | 2018-06-26 |
Date Mfgr Received | 2018-07-03 |
Device Manufacturer Date | 2017-04-25 |
Date Added to Maude | 2018-07-24 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MS. MELISSA THOMAS |
Manufacturer Street | 2880 MAIN STREET |
Manufacturer City | HOPKINTON NY 12965 |
Manufacturer Country | US |
Manufacturer Postal | 12965 |
Manufacturer Phone | 3153284491 |
Manufacturer G1 | NUMED, INC. |
Manufacturer Street | 2880 MAIN STREET |
Manufacturer City | HOPKINTON NY 12965 |
Manufacturer Country | US |
Manufacturer Postal Code | 12965 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | BIB CATHETER |
Generic Name | STENT PLACEMENT CATHETER |
Product Code | NVM |
Date Received | 2018-07-24 |
Returned To Mfg | 2018-07-17 |
Model Number | 420.1 |
Catalog Number | BB062 |
Lot Number | BIB-9161 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | NUMED, INC. |
Manufacturer Address | 2880 MAIN STREET HOPKINTON NY 12965 US 12965 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2018-07-24 |