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

Model Number	N/A
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The customer reported that the tip of spiral tip ureteral access catheter was found broken prior to use.The device did not come in contact with the patient.There was no patient harm reported and no additional procedures were required because of this failure.
Additional Manufacturer Narrative
Investigation - evaluation: a review of complaint history, device history record, trends, and quality control data was conducted during the investigation.The complaint device was not returned therefore, device failure analysis and physical examination of the device used in this case could not be performed.A review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.A device history record review could not be performed as the complaint lot number was not provided.There is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.A complaint history search revealed this complaint to be one of two complaints associated with complaint lot number.Another complaint is (b)(4).Based on the provided information a definitive root cause cannot be established or reported at this time.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: SPIRAL TIP URETERAL ACCESS CATHETER
• Common Device Name: GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6563101
• Report Number: 1820334-2017-00992
• Device Sequence Number: 19020013
• Product Code: GBL
• UDI-Device Identifier: 00827002148734
• UDI-Public: (01)00827002148734(17)190909(10)7259034
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2017

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: 024505
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/18/2017
• Supplement Date Received by Manufacturer: 10/09/2017
• Initial Report FDA Received Date: 05/12/2017
• Supplement Report FDA Received Date: 10/24/2017
• Patient Sequence Number: 1