MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-19 for COVERED AND MOUNTED CP STENT 428 CMCP031 manufactured by Numed, Inc..
[80707307]
Device was returned for review. The covering is completely detached from the stent and one end of the stent has been expanded. The report states that the physician did not use the hemostasis tools provided by numed for the introduction of the device into the introducer. The instructions for use states "use of the tools supplied with stent is necessary to defeat the hemostasis valve without damaging the stent or covering. " it is probably that the covering detached because the provided tools were not used as is specified in the instructions for use.
Patient Sequence No: 1, Text Type: N, H10
[80707308]
As per the report from bis "physician stated that the covering was not right on this item and the stent would not fo into the introducer properly. " additional information from bis was sent on 7/11/2017. "in an email from the account: physician used saline during prep. The hemostasis tools provided by numed were not used. A 14fr mullins sheath was used. The covering never entered the introducer or the patient. The covering was very loose on the distal tip - not right. Regarding the introducer - the stent would not go in - thus it was not proper. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1318694-2017-00020 |
| MDR Report Key | 6725904 |
| Date Received | 2017-07-19 |
| Date of Report | 2017-07-19 |
| Date of Event | 2017-06-28 |
| Date Mfgr Received | 2017-06-30 |
| Device Manufacturer Date | 2014-08-13 |
| Date Added to Maude | 2017-07-19 |
| 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 AND MOUNTED CP STENT |
| Generic Name | AORTIC STENT |
| Product Code | PNF |
| Date Received | 2017-07-19 |
| Returned To Mfg | 2017-07-18 |
| Model Number | 428 |
| Catalog Number | CMCP031 |
| Lot Number | CMCP-0576 |
| Device Expiration Date | 2019-08-31 |
| Operator | PHYSICIAN |
| 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 | 2017-07-19 |