MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-27 for FLEXI-TIP DUAL-LUMEN URETERAL ACCESS SET G17323 AQ-022610 manufactured by Cook Inc.
[140167564]
(b)(4). 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
[140167565]
It was reported that a (b)(6) female underwent a percutaneous nephrolithotomy. Cook's flexi-tip dual-lumen ureteral access set, (gpn:(b)(4)) was utilized during this case. A nephroscope was used concomitantly with cook's device. During the case it was observed that pieces of the dual lumen sheared off in the patient's kidneys. The fragments were flushed out of the kidneys with saline and will be returned to the manufacturer for evaluation. The procedure was completed as usual. No additional procedures were needed and the patient did not experience any adverse effects, nor were any adverse events reported as a result of this issue. The patient was discharged from the hospital (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-00664 |
| MDR Report Key | 8458329 |
| Date Received | 2019-03-27 |
| Date of Report | 2019-05-17 |
| Date of Event | 2019-02-12 |
| Date Mfgr Received | 2019-05-08 |
| Device Manufacturer Date | 2019-01-10 |
| Date Added to Maude | 2019-03-27 |
| 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 | 0 |
| Brand Name | FLEXI-TIP DUAL-LUMEN URETERAL ACCESS SET |
| Generic Name | EYB CATHETER, URETERAL, GASTRO-UROLOGY |
| Product Code | EYB |
| Date Received | 2019-03-27 |
| Model Number | G17323 |
| Catalog Number | AQ-022610 |
| Lot Number | 9435863 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2019-03-27 |