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

Model Number G23406

Device Problems Device Damaged Prior to Use (2284); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 07/26/2017

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

The user facility reported during a ureteroscopy procedure and prior to use, the universa firm ureteral stent set was found to not have an opening on one end due to the opening was pinched.This device was not used.As reported, no additional procedures were required due to this reported device issue.No section of the device was left inside the patient's body.There were no adverse effects to the patient due to this device issue.Additional patient and event details have been requested but not received at the time of this report filing.

Manufacturer Narrative

Investigation ¿ evaluation: the investigation included a review of the device history record, quality control data, specifications, and trends.A visual inspection and functional testing of the returned device was also conducted.One universa firm ureteral stent with peel off label, lot number 7876227 was returned for evaluation.The original package and label were not returned.The tip of the distal coil was smashed flat.A.038 wire guide would not transition through the end hole of the coil.Returned device and investigation photographs were reviewed and were attached to this complaint.Review of the photographs confirmed the reported issue.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.A review of the device history record for lot number 7876227 showed no non-conformance associated with the reported failure mode.A review of complaint history revealed this is the only complaint that has been received against this complaint device lot number 7876227.Based on the information available and investigation results of the returned device, the root cause is unknown and no conclusion can be drawn.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: UNIVERSA FIRM 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: 6783946
• MDR Text Key: 82601139
• Report Number: 1820334-2017-02303
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002234069
• UDI-Public: (01)10827002234069(17)200501(10)7876227
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: G23406
• Device Catalogue Number: UFH-626-RT1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2017
• 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