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 |