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.
[64937574]
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, this may be likely to cause or contribute to a serious injury if it recurred. (b)(4). Investigation results: one used bush bilateral illuminating catheter was returned. The returned device was visually inspected and found to have the black protective sleeve melted and separated on each of the two catheters 2cm and 1cm respectively at the distal end of the junction of the black protective sleeve and the clear optical fiber. 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) provides the following note: "start illumination with the light source at 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. " a photo provided by the customer indicated an integra light source was used to illuminate the fit. The light source setting was requested, but was not provided by the reporter. 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
[64937575]
The bush ureteral illuminating catheter was utilized with the integra light source. During the procedure, the black casing melted at the junction of the clear optical fiber and the black protective sleeve. Although the information was requested, the settings of the light source was requested but not provided. However, it was reported that the procedure was successfully completed and the patient did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2017-00118 |
| MDR Report Key | 6250642 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-01-13 |
| Date of Report | 2017-07-14 |
| Date of Event | 2015-07-20 |
| Date Mfgr Received | 2017-06-29 |
| Device Manufacturer Date | 2015-05-01 |
| 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 | 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 | 2017-01-13 |