MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2008-09-05 for NOVY CORNUAL CANNULATION SET J-NCS-503570 manufactured by Cook Urological, Inc..
[17768008]
"tip of novy catheter dropped off into the pt's uterus. Tip of novy catheter retrieved hysteroscopically with graspers. "
Patient Sequence No: 1, Text Type: D, B5
[17969960]
One used guide catheter was received noting the catheter to be separated into two segments near the bonded area. A scrape mark was observed on the catheter starting at the point of separation and continued toward the hub; several gouges were also noted near the point of separation. The customer indicated a 12 degree olympus hysteroscope with 5fr working channel scope was used during the procedure. Upon examination of the point of separation, the inner wires were noted to be protruding and bent over the end of the catheter. This catheter has inner wires to aid the physician should they want to turn the catheter to assure stability. Three catheters from production were test pulled and all three catheters separated beyond specification. Two catheters were bent to approx a 90 degree angle before test pulling in an attempt to recreate the bent wire appearance of the complaint product noting the inner wires on all three catheters were straight at the point of separation. Unable to determine what has caused the customers difficulty, add'l investigation is currently underway. When additional info becomes available, it will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825146-2008-00029 |
| MDR Report Key | 1151445 |
| Report Source | 01,08 |
| Date Received | 2008-09-05 |
| Date of Event | 2008-08-05 |
| Date Facility Aware | 2008-08-08 |
| Date Mfgr Received | 2008-08-08 |
| Device Manufacturer Date | 2007-12-18 |
| Date Added to Maude | 2008-09-12 |
| 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 | TAMMY BACON, MANAGER |
| Manufacturer Street | 1100 WEST MORGAN ST. |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal | 47460 |
| Manufacturer Phone | 8123331066 |
| 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 | 2008-09-05 |
| Returned To Mfg | 2008-08-26 |
| Model Number | NA |
| Catalog Number | J-NCS-503570 |
| Lot Number | U1697762 |
| Device Expiration Date | 2010-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1173838 |
| Manufacturer | COOK UROLOGICAL, INC. |
| Manufacturer Address | SPENCER IN 47460 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-09-05 |