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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow up report will be send upon conclusion.
Event or Problem Description
It was reported by the user facility that a patient underwent a cholecystectomy laparoscopy with ioc procedure.The surgery staff has reported that they have come across a defective angled tip ureteral catheter set prior to patient contact.The staff reported that the small cap on the end is not attached and just loose in the packaging.However, the procedure was completed with a different catheter and no additional procedures or adverse effects on the patient were warrant due to this occurrence.No further information was provided.
Additional Manufacturer Narrative
Investigation/evaluation: one complaint device was received in the open package with label lot number 7367362.The catheter was returned without the adapter.There was no indentation observed on the material to indicate the adapter had been tightened down properly on the proximal end where the adapter should have been located.If the adapter was loose it could have slipped off and been lost during the catheter packaging processes or when it was being removed from the package.Since the package was opened when received it cannot be confirmed if the adapter was not inside the package prior to opening the pouch.There is no indication that a design or process related failure mode contributed to this event.A review of the device history record of the finished product shows two non-conformances.These two issues were unrelated to the reported failure mode.A review of complaint history revealed two complaints associated to this complaint lot number.Another complaint for the same failure was received from the same customer.Based on the information provided and the results of our investigation; a definitive root cause was not able to be determined.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.The appropriate personnel have been notified of this complaint report.

• Brand Name: ANGLED 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: 6525783
• Report Number: 1820334-2017-00723
• Device Sequence Number: 1594723
• Product Code: GBL
• UDI-Device Identifier: 00827002145986
• UDI-Public: (01)00827002145986(17)191018(10)7367362
• Combination Product (Y/N): N
• Initial Reporter State: WY
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2017

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 023105
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/29/2017
• Supplement Date Received by Manufacturer: 09/20/2017
• Initial Report FDA Received Date: 04/27/2017
• Supplement Report FDA Received Date: 09/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1