MAUDE Adverse Event Report: COOK INC WHISTLE TIP URETERAL CATHETER; GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY

Catalog Number	022203
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/08/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
During a retrograde polygram procedure, when the catheter was being removed, it broke in three pieces.The physician was able to remove all of the pieces.The physician used another of the same device from a different lot number to complete the procedure with no further complications.No harm to the patient and no additional procedures or intervention was required due to this occurrence.Additional information received on 08mar2016- the catheter broke at the beginning of the case after it went through the cystoscope.No dye had been injected through it.The physician pulled the remnants of the catheter out with a forcep.(b)(6) 2016.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, device history record, documentation, manufacturing instructions, specifications, quality control and visual inspection of the returned device was conducted during the investigation.This product is not provided with an ifu.The cook whistle tip ureteral catheter is use for drainage and retrograde pyelograms.The visual inspection of the returned device reported: catheter returned coiled bunched together inside the package.Catheter separated 18.1cm from distal tip, separation occurred below the ink mark.Proximal segment measured 51.5 cm full length (69.6cm) of catheter was returned.Severe kinks visualized on the proximal catheter segment.From the point of separation, two severe kinks were observed, one @ 34 cm and the second @ 44.9cm.No kinks visualized on the distal separated catheter segment.The complaint device was returned therefore, an investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.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 information provided, and the results of our investigation, it was evidence to indicate the catheter was subjected to excessive force but a definitive root cause could not be determined.The appropriate internal personnel have been notified.We will continue to monitor for similar complaints.Per the risk assessment no further action is required.
Event or Problem Description
During a retrograde polygram procedure, when the catheter was being removed, it broke in three pieces.The physician was able to remove all of the pieces.The physician used another of the same device from a different lot number to complete the procedure with no further complications.No harm to the patient and no additional procedures or intervention was required due to this occurrence.Additional information received on 08mar2016- the catheter broke at the beginning of the case after it went through the cystoscope.No dye had been injected through it.The physician pulled the remnants of the catheter out with a forcep.

• Brand Name: WHISTLE TIP URETERAL CATHETER
• Common Device Name: GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5534388
• Report Number: 1820334-2016-00180
• Device Sequence Number: 11006145
• Product Code: GBL
• UDI-Device Identifier: 00827002140363
• UDI-Public: (01)00827002140363(17)180609(10)NS5909630
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 022203
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/08/2016
• Device Age: 8 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2016
• Supplement Report FDA Received Date: 01/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention