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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/29/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow up report will be send upon conclusion.

Event 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.

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
• Type of Device: GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
• 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: 6525783
• MDR Text Key: 74040812
• Report Number: 1820334-2017-00723
• Device Sequence Number: 1
• Product Code: GBL
• UDI-Device Identifier: 00827002145986
• UDI-Public: (01)00827002145986(17)191018(10)7367362
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 023105
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/29/2017
• Initial Date FDA Received: 04/27/2017
• Supplement Dates Manufacturer Received: 09/20/2017
• Supplement Dates FDA Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1