MAUDE Adverse Event Report: COOK INC UNIVERSA SOFT URETERAL STENT SET; FAD STENT, URETERAL

Model Number G49945

Device Problems Break (1069); Insufficient Information (3190)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 07/25/2017

Event Type  malfunction  

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 Description

A letter was received from the distributor advising that the attachments contained the submission of the complaint.Only a photograph of a damaged universa soft ureteral stent set was attached to the letter.Multiple follow-up attempts have been made to obtain patient, device, and event details with no response received at the time of this filing.Patient status is unknown as information was not provided by the reporter.

Manufacturer Narrative

(b)(4).A review of specifications 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.Based on the provided information, no product returned and the investigation, 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.

Event Description

The device end was broken: split on pigtail.The catheter had no contact with the patient.

• Brand Name: UNIVERSA SOFT URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• 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: 6828868
• MDR Text Key: 83988608
• Report Number: 1820334-2017-02772
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002499454
• UDI-Public: (01)00827002499454(17)200412(10)7826377
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2018

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: No Information
• Device Model Number: G49945
• Device Catalogue Number: USH-600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/18/2017
• Initial Date FDA Received: 08/29/2017
• Supplement Dates Manufacturer Received: 01/30/2018
• Supplement Dates FDA Received: 03/01/2018
• Date Device Manufactured: 04/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1