MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-15 for COVERED MOUNTED CP STENT 428 CMCP033 manufactured by Numed, Inc..
[142327326]
The production records were reviewed for the cmcp and d'vill device. No issues were found with either of them. The cmcp was returned in a biohazard bag. A boston scientific indeflatory is attached to the cmcp outer balloon extension. The outer balloon is partially inflated. It required five full rotations of the indeflator's handle to remove all of the contrast from the balloon. The stent has been removed from the catheter. It has been completely flattened, and three of the adhesive spots are detached. The d'vill introducer was not returned. A comparative d'vill and cmcp device of equivalent sizes were pulled and tested. The comparative cmcp was the same balloon diameter as the complaint device. The comparative cmcp was passed through the proximal end of the comparative d'vill used the 14f hemostasis tool. The cmcp easily entered the sheath. The same cmcp was passed through the hemostasis valve without the hamostasis valve tool. The stent was forced off the back of the balloon as it passed through the valve. There is a statement in the instructions for use that states: "use of the tools supplied with the stent is necessary to defeat the hemostasis valve without damaging the stent or covering. Refer to insert ifu-cpce. Once the stent is past the hemostasis valve, the tool must be pulled out of the valve. " it is likely that the complaint stent came off of the balloon because the hemostasis valve tool was not used when the catheter/stent combination was being inserted into the hemostasis valve of the sheath.
Patient Sequence No: 1, Text Type: N, H10
[142327327]
As per the incident report sent to numed by the distributor - "the cp stent could not fit through the d'vill 14 french. The stent came off of the balloon. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1318694-2019-00009 |
| MDR Report Key | 8513841 |
| Date Received | 2019-04-15 |
| Date of Report | 2019-04-15 |
| Date of Event | 2019-03-15 |
| Date Mfgr Received | 2019-03-19 |
| Device Manufacturer Date | 2015-12-11 |
| Date Added to Maude | 2019-04-15 |
| 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 | 2019-04-15 |
| Returned To Mfg | 2019-03-27 |
| Model Number | 428 |
| Catalog Number | CMCP033 |
| Lot Number | CMCP-1106 |
| 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 | 2019-04-15 |