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

Model Number	G14030
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical devices: laparoscope, electrosurgical unit, scissors, graspers, dissectors, coagulators.Pma/510k #: preamendment.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It is reported a patient had a radical hysterectomy with bilateral oophorectomy and placement of bilateral cook whistle tip ureteral catheters.Two days later, urine leakage was observed.Three days after urine leakage was noted, it was arranged for the cook whistle tip ureteral catheters to be removed by a urologist.At this time it was found that one of the catheters was broken and a part was left inside the patient's body.An unspecified time period later, surgery was arranged to remove the retained section of the catheter.The patient's outcome was good.No additional consequences to the patient have been reported.Additional details regarding the patient and the event have been requested.At this time, no further information has been provided.
Event or Problem Description
Additional information provided: the device segment was removed via ureteroscopy.The catheter was not replaced.An investigation of the situation completed at the complaint facility concluded that this issue was not caused by this device.
Additional Manufacturer Narrative
Investigation/evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, the device history record, instructions for use, manufacturing instructions, specifications, and quality control data.The complainant returned two used ureteral catheters, part number 022105 for investigation.The package and label were not returned, lot number could not be confirmed.Visual examination confirmed one catheter was received measuring 69.5cm long; no manufacturing anomalies observed on this catheter.One catheter was severed in two locations.The distal segment measures 20.2cm from distal tip to point of separation; the distal tip was not closed, 7mm of the tip including the notch port was missing.The point of separation is smashed and pulled to separation.The proximal segment measures 47.8cm long, point of separation is smashed and with a melted appearance.Proximal end of this segment has been cut at an angle.Review of the device history record (dhr) showed no non-conformances related to this failure mode.A search of the complaint database revealed no other complaints associated with the reported lot number.A review of production processes and quality inspection documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Two catheters were returned, one was separated in two locations the other shown no anomalies.The device that was separated appears melted at one separation point and at the other separation point that it had separated under tensile load.A 7mm section at the distal tip of the device was not returned.The complaint was confirmed based on the returned device.The cause of the complaint cannot be established.A risk analysis was conducted and concluded no additional risk reduction was required.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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: 8613447
• Report Number: 1820334-2019-01112
• Device Sequence Number: 11268148
• Product Code: GBL
• UDI-Device Identifier: 00827002140301
• UDI-Public: (01)00827002140301(17)220110(10)NS9435832
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/10/2022
• Device Model Number: G14030
• Device Catalogue Number: 022105
• Device Lot Number: NS9435832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Initial Date Received by Manufacturer: 04/29/2019
• Supplement Date Received by Manufacturer: 06/23/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 07/12/2019
• 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: Other
• Patient Age: 62 YR
• Patient Weight: 61