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

Model Number N/A

Device Problem Kinked (1339)

Patient Problem No Patient Involvement (2645)

Event Date 06/29/2017

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 and/or completion of the investigation.

Event Description

It was reported that the physician noticed that the universa firm ureteral stent was kinked while still in the package.The physician decided not to use the device because a wire guide would not be able to pass through the kinking.A new device was opened and used to complete the procedure.There were no adverse events or injury to the patient as the event occurred prior to patient contact.

Manufacturer Narrative

Investigation ¿ evaluation: the investigation included a review of complaint history, the device history record, and product specifications.Visual inspection and functional testing of the returned device was also conducted.One opened universa firm ureteral stent set package labeled rpn ufh-622, lot 7622404 was received.The stent was returned without the tether and positioner.Visual examination confirmed the distal coil tip was smashed flat.An hsf-38-50-qc wire guide with a diameter of.0392" would not transition through the smashed tip.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 showed there were no non-conformances identified during the manufacturing process.A review of complaint history for this product/lot number combination revealed this is the only complaint that has been received against this complaint device lot number; 7622404.Based on the provided information the definitive root cause cannot be determined.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: 6731936
• MDR Text Key: 80693553
• Report Number: 1820334-2017-01837
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002498723
• UDI-Public: (01)00827002498723(17)200125(10)7622404
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/11/2017

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: UFH-622
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2017
• Initial Date FDA Received: 07/21/2017
• Supplement Dates Manufacturer Received: 12/05/2017
• Supplement Dates FDA Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 1820334-2017-01837
• Patient Sequence Number: 1
• Patient Age: 48 DA