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

Model Number	N/A
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/29/2017
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 and/or completion of the investigation.
Event or Problem 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.
Additional 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
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6731936
• Report Number: 1820334-2017-01837
• Device Sequence Number: 10995925
• Product Code: FAD
• UDI-Device Identifier: 00827002498723
• UDI-Public: (01)00827002498723(17)200125(10)7622404
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K961446
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UFH-622
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/29/2017
• Supplement Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 07/21/2017
• Supplement Report FDA Received Date: 12/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1820334-2017-01837
• Patient Sequence Number: 1
• Patient Age: 48 DA