MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-05-14 for OPEN-END FLEX-TIP URETERAL CATHETER 021305 manufactured by Cook, Inc..
[5853806]
The initial reporter states that the cook catheter did not fail. However, during the procedure, the physician's technique (while using another manufacturer's vessel sealer), melted 5 cm of the catheter, stent placement was needed. Per attached medsun report ((b)(4)): lap exploratory colon resection. The catheter was removed at conclusion of case and was observed to be shorter than preoperatively. An x-ray in the or (operating room) confirmed a segment of the catheter lying with in the mid left ureter. The urologist was called back into the operating room. A cystourethroscopy showed no bladder damage. A small clot, coming from the left ureteral orifice was seen. The urologist encountered at the l5 level of the left ureter, what appeared to be a thermal injury with oozing present at the 11 o'clock to 2 o'clock position extending for 2-3 centimeters. The ureteroscope demonstrated no evidence of a tear. A 6 fr contour stent was passed and in excellent condition within the collection system. The surgeon stated in a brief interview that the other manufacturer's device caused a thermal burn and attributed it to user error and not device failure. The patient was discharged to a rehab facility on op day #7. The catheter and stent were removed via forceps. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
[13299375]
Expiration date unknown as lot is unknown. (b)(4). The event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2015-00282 |
| MDR Report Key | 4781763 |
| Report Source | 07 |
| Date Received | 2015-05-14 |
| Date of Report | 2015-04-10 |
| Date of Event | 2015-04-10 |
| Date Facility Aware | 2015-04-10 |
| Report Date | 2015-04-15 |
| Date Mfgr Received | 2015-04-15 |
| Date Added to Maude | 2015-05-20 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LARRY POOL, MANAGER |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPEN-END FLEX-TIP URETERAL CATHETER |
| Generic Name | NEEDLE, BIOPSY, CARDIOVASCULAR |
| Product Code | DWO |
| Date Received | 2015-05-14 |
| Model Number | NA |
| Catalog Number | 021305 |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-05-14 |