MAUDE Adverse Event Report: COOK INC BUSH URETERAL ILLUMINATING CATHETER SET; FCS CATHETER, LIGHT, FIBEROPTIC, GLASS, URETERAL

Model Number N/A

Device Problem Overheating of Device (1437)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: one used bush illuminating catheter was returned.The returned device was visually inspected and found melted and separated 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." although requested, cook inc.Was not able to determine the light source used during this reported event or the setting for that 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 (b)(4), (b)(4) and (b)(4)-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 ((b)(4)).

Event Description

Prior to a procedure, the bush ureteral illuminating catheter burnt where the catheter connects to the light source cord.This observation was made prior to patient contact and there was no impact to a patient or end user.

Manufacturer Narrative

A review of the complaint history, device history record, instructions for use (ifu), specifications, and visual inspection of the returned device was conducted during the investigation.One used light guide was returned.The protective sleeve and part of the optical fiber light guide assembly separated and attached to the clear optical fiber and catheter.The separated section was melted indicating the device was overheated.The lot number of the device is not known; accordingly a review of the device history record could not be conducted.The ifu notes to 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.A variety of light sources may be used.High-energy light sources, such as xenon light sources, require a plug adapter available from the light source manufacturer.Evidence displayed indicates the device has been exposed to high energy too long.The root cause was determined to be a lack of testing on methods to prevent overheating and what precise power levels lead to overheating.Measures have been conducted to address this failure mode.Monitoring will continue to be performed for similar complaints.

• Brand Name: BUSH URETERAL ILLUMINATING CATHETER SET
• Type of Device: FCS CATHETER, LIGHT, FIBEROPTIC, GLASS, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6250645
• MDR Text Key: 65093957
• Report Number: 1820334-2017-00117
• Device Sequence Number: 1
• Product Code: FCS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 084120
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/18/2014
• Initial Date FDA Received: 01/13/2017
• Supplement Dates Manufacturer Received: 06/29/2017
• Supplement Dates FDA Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1870-2017
• Patient Sequence Number: 1