MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-09-17 for BUSH SINGLE LUMEN URETERAL ILLUMINATING CATHETER SET J-BICS-058020 manufactured by Cook Urological Inc.
[16093385]
The product was not received for evaluation, however, the attending physician stated a urologist placed the illuminating catheter and was not familiar with the ob/gyn version of the set. The main catheter differences are the location of the illumination portions. The urological version, the lighted portion begins at the tip of the catheter, while the lighted portion for the ob/gyn starts 10. 5cm from the tip of the catheter. Upon advancing the ob/gyn version into ureters most likely the non-illuminated portion of the catheter was not considered. Additional information received was: the patient suffered from a blood clot due to placement called hydronephrosis and was then stented thru a process called nephrostomy thru the ureters to break up the clot. The incident occurred in one kidney area and that the patient is currently doing fine.
Patient Sequence No: 1, Text Type: N, H10
[16164314]
Dr. (b)(6) told me that the urologist who had placed the bush illuminating stent, for another gyn physician, too far and caused damage to the patient near the kidney area. The urologist was not familiar with gyn test. The gyn physician felt that if the gyn stent had been only 15cm in length and no where near the kidneys this probably would not have happened. Stent was not used by dr. (b)(6) but another physician (unknown).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825146-2010-00038 |
| MDR Report Key | 1845941 |
| Report Source | 07 |
| Date Received | 2010-09-17 |
| Report Date | 2010-09-16 |
| Date Mfgr Received | 2010-08-18 |
| Date Added to Maude | 2010-09-30 |
| 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 | 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 | BUSH SINGLE LUMEN URETERAL ILLUMINATING CATHETER SET |
| Generic Name | FCS CATHETER, LIGHT, FIBEROPTIC, GLASS, URETERAL |
| Product Code | FCS |
| Date Received | 2010-09-17 |
| Model Number | NA |
| Catalog Number | J-BICS-058020 |
| Lot Number | UNK |
| 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 | 2010-09-17 |