MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-01-13 for BUSH URETERAL ILLUMINATING CATHETER SET N/A 084120 manufactured by Cook Inc.
[64917258]
This mdr is being submitted past the 30 day reporting requirement as part of a retrospective review of the report that was initiated during an fda inspection. A retrospective review of the complaint record determined that this report should have been submitted as a malfunction report. In this case, no patient injury occurred; however, it may be likely to cause or contribute to a serious injury if patient contact did occur. (b)(4). Investigation findings: the complaint device was not returned for investigation. Per the customer? S statement? The black material overheated?. A document review was conducted. Device functionality is tested 100% to assure no debris or damage during quality control process. Cook inc. Has received similar reports of this device melting at this junction. According to our previous investigations, the most likely cause is overheating due to a high light source setting over an extended period of time. Cook inc. Has received adverse event reports related to this issue. The ifu (t_bdlslc_rev0) recommends the following: the anodized aluminum plugs on the light guides fit a standard circon-a. C. M. I light source. If using a different light source, an adapter may be required to successfully use the bush dl or bush sl ureteral illuminating catheter. Adapters are available from various light source manufacturers. The ifu also provides the following note: "start illumination with the light source on the lowest setting, as many light sources produce thermal energy at varying temperatures. This will limit the possibility of thermal damage at the catheter/ light plug junction. It is inadvisable to use any light source at its highest setting, unless the light source's actual thermal energy output is known. " additionally, the ifu notes: "this catheter will not transmit thermal energy along its light fibers to patient tissue. Any excessive thermal damage from the light source will manifest at the catheter/light plug junction, and will not be transmitted along the catheter length. " two additional requests were made for product return. However, the complaint device was not returned; therefore, a physical examination of the complaint device could not be performed. If the complaint device becomes available for investigation, the device will be evaluated and the file will be updated at that time. The light source used was the integra luxtec mlx light box. Although requested, cook inc. Was not able to determine the setting for the light source. A review of the device history record did not indicate any manufacturing anomalies. During manufacturing this device is illuminated and inspected using a storz light source at a controlled setting. The ifu also states,? A variety of light sources may be used. The supplied plug fits a standard circon- a. C. M. I. Light sources mv9082, mv9083 and alv-1. Storz, olympus and other light sources may be used. High energy light sources, such as xenon, may cause overheating of the anodized aluminum plug. An appropriate adapter (available from most light source manufacturers) will ensure product safety and functionality. For storz xenon light source, use "turret adapter 487uo. " conclusion: the most likely cause of this reported event is overheating due to a high light source setting over an extended period of time. A stop ship has been executed to prevent further distribution until this issue is better understood. A capa has been opened to investigate this issue further (ref capa # (b)(4)).
Patient Sequence No: 1, Text Type: N, H10
[64917259]
It is alleged that the bush ureteral illuminating catheter was utilized via cystoscopy. The illuminating catheter was placed directly into the integra light box and overheated the black material where the lighted stents are inserted. The catheters were immediately removed and there was no intervention reported. 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
| Report Number | 1820334-2017-00119 |
| MDR Report Key | 6250682 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-01-13 |
| Date of Report | 2017-07-18 |
| Date of Event | 2016-04-11 |
| Date Mfgr Received | 2017-06-30 |
| Device Manufacturer Date | 2016-02-15 |
| Date Added to Maude | 2017-01-13 |
| 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 |
| Removal Correction Number | Z-1870-2017 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BUSH URETERAL ILLUMINATING CATHETER SET |
| Generic Name | FCS CATHETER, LIGHT, FIBEROPTIC, GLASS, URETERAL |
| Product Code | FCS |
| Date Received | 2017-01-13 |
| Model Number | N/A |
| Catalog Number | 084120 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2017-01-13 |