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

Model Number	G49913
Medical Device Problem Code	Split (2537)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/13/2017
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 area representative reported during an antegrade placement of a ureteral stent, the surgeon used the universa firm ureteral stent set.When the surgeon removed the tether, the pigtail was split.A new universa stent was opened and used to complete the procedure.As reported, this occurred in consecutive cases.There was no part of the device left inside the patient¿s body.No additional procedures were required due to this occurrence.There were no adverse effects or consequences to the patient.Manufacturer report #¿s 1820334-2017-03616 (first case) and 1820334-2017-03617 (second case) have been submitted to capture the consecutive cases in which the pigtail was split when the tether was removed.The surgeon expressed that he intensely dislikes the braided tethers that come with the universa stents and would prefer they come with the monofilament tethers that are sold in the united states.
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 the device history record, complaint history, the instructions for use, manufacturing instructions and quality control data.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; 7931750.Based on the provided information the definitive root cause is inconclusive.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: 6976254
• Report Number: 1820334-2017-03616
• Device Sequence Number: 19115387
• Product Code: FAD
• UDI-Device Identifier: 10827002499130
• UDI-Public: (01)10827002499130(17)200522(10)7931750
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K961446
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2017

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: G49913
• Device Catalogue Number: UFH-724-R
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/13/2017
• Supplement Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 10/25/2017
• Supplement Report FDA Received Date: 12/13/2017
• Patient Sequence Number: 1