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

Model Number	G49873
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	07/11/2017
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 or completion of the investigation.
Event or Problem Description
The user facility contact reported during a right ureteroscopy with stent placement, the universa firm ureteral stent set was pinched shut at the proximal end of the stent and therefore would not pass over the wire guide.According to the reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Corrected data: additional event information has been received.The universa firm ureteral stent set was not used on the patient due to the end of the stent being pinched shut.The physician noticed the issue before placement.Another universa firm ureteral stent was used to complete the procedure.Date received by manufacturer 07/11/2017.Corrected data: additional event information has been received.The universa firm ureteral stent set was not used on the patient due to the end of the stent being pinched shut.The physician noticed the issue before placement.Another universa firm ureteral stent was used to complete the procedure.Date received by manufacturer 07/11/2017.
Additional Manufacturer Narrative
Investigation ¿ evaluation: the universa firm ureteral stent was not returned for evaluation and no photographs were provided.Without the complaint device, a physical investigation was not able to be completed.The investigation included a review of complaint history, the device history record, documentation, and specifications.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 one non-conformance associated with the complaint device lot number 7788264.The issue identified was related to a single device with an incorrectly applied label.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; 7788264.Based on the information available, 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
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6763923
• Report Number: 1820334-2017-02164
• Device Sequence Number: 13830112
• Product Code: FAD
• UDI-Device Identifier: 00827002498730
• UDI-Public: (01)00827002498730(17)200329(10)7788264
• 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: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/14/2017

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: G49873
• Device Catalogue Number: UFH-624
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/18/2017
• Supplement Date Received by Manufacturer: 08/04/2017; 12/12/2017
• Initial Report FDA Received Date: 08/03/2017
• Supplement Report FDA Received Date: 08/07/2017; 12/14/2017
• Patient Sequence Number: 1