MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-11-14 for FLEXI-TIP DUAL-LUMEN URETERAL ACCESS SET N/A AQ-022610 manufactured by Cook Inc.
[59758025]
(b)(4) the event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[59758026]
It was reported during a ureteroscopy in the upper urinary tract the tip of the dual lumen catheter broke off into the kidney and had to be retrieved using graspers. No additional information was available at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
[75134867]
Investigation - evaluation: a review of the complaint history, device history record, quality control, specification and visual inspection of the returned device was conducted during the investigation. The device was returned for evaluation. A visual examination of the returned device showed the flexible tip was separated from the rest of the catheter. There is no indication that a design or process related failure mode contributed to this event. Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident. Review of device history record shows no nonconforming events which could contribute to this failure mode. It should be noted there were no other reported complaints for this lot number. Based on the provided level of information, a definitive root cause cannot be determined or reported at this time. We will continue to monitor for similar complaints. Per the quality engineering risk assessment no further action is required. Per the risk assessment no further action is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2016-01295 |
| MDR Report Key | 6098775 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-11-14 |
| Date of Report | 2017-05-10 |
| Date of Event | 2016-10-20 |
| Date Mfgr Received | 2017-05-04 |
| Device Manufacturer Date | 2016-07-14 |
| Date Added to Maude | 2016-11-14 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXI-TIP DUAL-LUMEN URETERAL ACCESS SET |
| Generic Name | EYB CATHETER, URETERAL, GASTRO-UROLOGY |
| Product Code | EYB |
| Date Received | 2016-11-14 |
| Model Number | N/A |
| Catalog Number | AQ-022610 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 1. Required No Informationntervention | 2016-11-14 |