MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-06-21 for OPEN-END URETERAL CATHETER 020013 manufactured by Cook Inc.
[112454778]
(b)(4). Pma/510k #? Pre-amendment. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[112454779]
It was reported, during a retrograde pyelogram / catheter insertion procedure that the open-end ureteral catheter was inserted for use, and part of ureteral catheter disintegrated and was spotted in left ureteral orifice (uo). This part was then retrieved from the patient. The case, as reported, was a 3 stage surgery that started off with a rigid cystoscopy first. A ureteric catheter was inserted by the doctor retrograde for a pyelogram, soon after there was an unidentified green string-like object with black spots dangling from the uo spotted on the camera screen. The doctor and her assistant were notified and asked for a grasper to retrieve the object and it was removed. Upon taking out the ureteral catheter it was found that part of the outer side of the ureteral catheter had disintegrated. Surgeons did a visual inspection with rigid cystoscope. It was further reported that the patient's anatomy was not tortuous or calcified. It was further clarified that the insertion was easy and while doing the pyelogram and pushing the sheath up it was noted that the "sheath" was coming off. Once the catheter was removed the dislodged piece was removed with forceps. It was further states that the ureteric orifice was looking traumatized and there was a little more hematuria than normal for a pyeloplasty. The customer stated that the patient was otherwise well. No report of any serious injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-01692 |
| MDR Report Key | 7627732 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-06-21 |
| Date of Report | 2018-07-13 |
| Date of Event | 2018-06-04 |
| Date Mfgr Received | 2018-07-12 |
| Device Manufacturer Date | 2018-01-16 |
| Date Added to Maude | 2018-06-21 |
| 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 | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPEN-END URETERAL CATHETER |
| Generic Name | GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY |
| Product Code | GBL |
| Date Received | 2018-06-21 |
| Returned To Mfg | 2018-07-12 |
| Catalog Number | 020013 |
| Lot Number | 8513662 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-06-21 |