MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2011-07-29 for NOVY CORNUAL CANNULATION SET J-NCS-503570 manufactured by Cook Urological, Inc..
[2038512]
The physician was using a novy cornual cannulation set during an hsg/ssg procedure. While navigating the catheter within the patient to get the catheter in place to expel the contrast media, the guide tip (3/4 inch) fell off into the patient. They were able to retrieve the tip. The procedure had to be redone with a new novy cornual cannulation set.
Patient Sequence No: 1, Text Type: D, B5
[9142978]
At this time, the device has not been returned for a proper evaluation. Additional attempts have been made to obtain information without success. Should additional information become available, it will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825146-2011-00029 |
| MDR Report Key | 2190981 |
| Report Source | 06,07 |
| Date Received | 2011-07-29 |
| Date of Report | 2011-07-29 |
| Date of Event | 2011-06-28 |
| Report Date | 2011-07-29 |
| Date Mfgr Received | 2011-06-29 |
| Device Manufacturer Date | 2011-05-19 |
| Date Added to Maude | 2011-08-08 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRIS KILANDER |
| Manufacturer Street | 1100 WEST MORGAN |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal | 47460 |
| Manufacturer Phone | 8128294891 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOVY CORNUAL CANNULATION SET |
| Generic Name | MOV CATHETER, SALPINGOGRAPHY |
| Product Code | MOV |
| Date Received | 2011-07-29 |
| Model Number | NA |
| Catalog Number | J-NCS-503570 |
| Lot Number | U2066978 |
| Device Expiration Date | 2014-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK UROLOGICAL, INC. |
| Manufacturer Address | SPENCER IN 47460 US 47460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-07-29 |