MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-28 for COVERED MOUNTED CP STENT 428 CMCP025 manufactured by Numed, Inc..
[135522669]
The complaint stent, bib and ring mandril were returned in separate (b)(6) bags. All of the returned components are clean and free of blood. The covering is detached and was not returned. The adhesive spots are visible on the stent. The stent has been slightly flattened. The catheter was returned with (2) 0. 015 mandrils in the guidewire lumen. There is no blood on the catheter and no contrast in the balloon. The balloon has very well defined folds. The condition of the stent and the bib leads us to believe that they never entered he introducer. The stent and catheter are both completely free of blood and the balloon still has well defined folds that would not be present if the "poba" had occurred. At this time it is impossible to determine the actual nature of the complaint, which makes it impossible to determine the root cause. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[135522670]
As reported to numed - "in the first instance we were able to do 'poba' only as the stent remained in the sheath itself. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1318694-2019-00004 |
| MDR Report Key | 8282446 |
| Date Received | 2019-01-28 |
| Date of Report | 2019-01-28 |
| Date of Event | 2018-12-06 |
| Date Mfgr Received | 2019-01-03 |
| Device Manufacturer Date | 2017-10-17 |
| Date Added to Maude | 2019-01-28 |
| 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. NICHELLE LAFLESH |
| 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 | COVERED MOUNTED CP STENT |
| Generic Name | AORTIC STENT |
| Product Code | PNF |
| Date Received | 2019-01-28 |
| Returned To Mfg | 2019-01-10 |
| Model Number | 428 |
| Catalog Number | CMCP025 |
| Lot Number | CMCP-1756 |
| 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 | 2019-01-28 |