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

Model Number N/A

Device Problem Partial Blockage (1065)

Patient Problems Concussion (2192); No Patient Involvement (2645)

Event Date 06/15/2017

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

It was reported that prior to performing an unspecified procedure, the physician found that the tapered end the universa firm ureteral stent set was closed shut and therefore he was unable to load the stent onto the wire.The device did not come in contact with the patient.The intended procedure was completed but at this time it is not known if the physician used another stent set from same or different lot.There was no known patient harm reported due to this occurrence.

Manufacturer Narrative

(b)(4).Investigation ¿ evaluation: one universa stent was received for evaluation.The tether has been removed from the stent and it was not returned.Debris was observed in the end hole and side ports.The tip of the distal coil device is smashed flat.An indentation was noted behind the distal tip end hole approximately 2mm.An hsf-038-50 qc wire guide could not be passed through the smashed area of the stent.The complaint has been confirmed.Based on the investigation evaluation, 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.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 review of the device history record did not reveal any information related to this device issue.A review of complaint history did not reveal any other complaints received that are associated with this device lot number 7754352.Based on the information available, a definitive root cause for the smashed end is unable to be determined.The device was received with an open package, therefore it could not be determined if this issue occurred during the manufacturing process or user handling of the device.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: 6685684
• MDR Text Key: 79039994
• Report Number: 1820334-2017-01588
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002234083
• UDI-Public: (01)10827002234083(17)200316(10)7754352
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961446
• 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: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: N/A
• Device Catalogue Number: UFH-630-RT1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2017
• 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