MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-12 for NUMED BIB CATHETER BB015 manufactured by Numed, Inc..
[142196148]
During right and left heart cardiac cath distal and proximal stent caths were placed. Initial balloon used for first (distal) stenosis was incorrect, was too large in diameter, and the inflation was stopped on purpose before full dilation. Due to the packaging on the balloon, catheter is not clearly marked as to what size is the inner and what size is the outer. This resulted in flaring of the stent distally and proximally. No rupture or bleeding seen and the remainder of the procedure was uneventful. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085855 |
| MDR Report Key | 8515103 |
| Date Received | 2019-04-12 |
| Date of Report | 2019-04-10 |
| Date of Event | 2019-04-03 |
| Date Added to Maude | 2019-04-15 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NUMED BIB CATHETER |
| Generic Name | CATHETER, ANGIOGRAPHY, PERIPHERAL, TRANSLUMINAL DUAL BALLOON |
| Product Code | NVM |
| Date Received | 2019-04-12 |
| Model Number | BB015 |
| Lot Number | BIB-1030-1 ST-1170 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUMED, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-12 |