MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-07 for BIB CATHETER 420.1 BB072 manufactured by Numed, Inc..
[116714098]
Numed, inc. Was made aware of incident from a returned post market clinical follow-up form. Incident was not reported by hospital. Physician did not think the rupture necessitated a formal complaint. Catheter was not returned. Balloon burst can not be confirmed. A comparative catheter from a different lot was pulled and tested for rated burst pressure. The labeled rbp for this device is 2. 0 atm. The comparative catheters outer balloon was inflated in 0. 5 atm increments until rbp (2. 0 atm) with no issues. It was then over inflated to 5. 0 atm, which is more than double the rbp, where it burst longitudinally. An inflation device with pressure gauge was used. Procedure was successful. Very little information has been received, even after repeated attempts.
Patient Sequence No: 1, Text Type: N, H10
[116714099]
Rupture of the outer balloon at 2 atm and full diameter. Withdrawal without problems.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1318694-2018-00010 |
| MDR Report Key | 7757950 |
| Date Received | 2018-08-07 |
| Date of Report | 2018-08-07 |
| Date of Event | 2017-11-23 |
| Date Mfgr Received | 2018-07-13 |
| Device Manufacturer Date | 2016-12-22 |
| Date Added to Maude | 2018-08-07 |
| 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 | 2018-08-07 |
| Model Number | 420.1 |
| Catalog Number | BB072 |
| Lot Number | BIB-8895 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-08-07 |