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

Model Number N/A

Device Problem Melted (1385)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation - evaluation: a review of the dimensional verification, documentation, instructions for use (ifu), quality control and visual inspection of the returned device was conducted during the investigation.The device is shipped with an instruction for use (ifu).In the ifu it states: 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.Note: start illumination with the light source at the lowest setting, as many light sources product 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.The visual inspection of the returned device reported that the device had 1 plug and 2 catheters.The red ink mark catheter doesn¿t have the teflon support sleeve.The length of the catheter measures 82 cm in length.The black ink mark catheter has the teflon support sleeve and measures 82.5 cm in length.A visual examination noted that 8mm of the black ink mark fiber is melted into the support sleeve of the catheter.Both ends of the fiber plug assembly have a melted appearance and have pulled apart.The fiber appears melted.Both catheters were noticeably used.There is no evidence to suggest that the product was not made to specifications.Review of device history and non-conformances was not possible as the lot number was not available.A definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.If the result of this investigation changes a follow up mdr will be submitted.

Event Description

It was reported by the user facility that a patient underwent an unspecified procedure using a bush ureteral illuminating catheter set.The attending physician indicated that after the procedure was completed the light fiber extensions were found to be split/snapped on both catheters above the bifurcation.There were no unintended sections of the device that remained inside of the patient¿s body, nor did the patient experience any adverse effects due to this occurrence.The device has been returned and the visual inspection of the received device revealed that the ends were melted.No further information was provided.

Manufacturer Narrative

Corrected information (04/07/2017): date of awareness of the initial report was corrected from 03/06/2017 to 02/22/2017.

• 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: 6431506
• MDR Text Key: 70770318
• Report Number: 1820334-2017-00551
• Device Sequence Number: 1
• Product Code: FCS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• 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?: Yes
• Date Manufacturer Received: 04/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1