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

Model Number	N/A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/22/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported by the user facility that a patient underwent an antegrade uretic stent placement via access from the kidney.A universal firm ureteral stent set was used.The attending physician indicated that during the removal of the amplatz wire, it got stuck in the stent and could not be removed.The two physicians had to remove the stent and wire together out of the patient as one unit.The wire was then separated and removed and a new stent was deployed.There were no unintended sections of the device that remained inside of the patient¿s body, nor did the patient experience any additional procedures or adverse effects due to this occurrence.No further information was provided.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, dimensional verification, device history record, documentation, specifications, trends, quality control and visual inspection of the returned device was conducted during the investigation.Review of production and quality documentation did not observe any specific issues with current controls that may have contributed to this incident.In addition, a review of device history record did not observe any non-conformances that may have contributed to this incident.The wire guide returned for physical evaluation is not the wire guide that was supplied with the ufh-600 stent set.Based on the provided information and the returned product evaluation, the root cause is due to the physician using a different wire guide than the supplied one.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.Per the risk assessment no further action is required.

• 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: 6321600
• Report Number: 1820334-2017-00155
• Device Sequence Number: 577679
• Product Code: FAD
• UDI-Device Identifier: 00827002498778
• UDI-Public: (01)00827002498778(17)180812(10)6114485
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K961446
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UFH-600
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2017
• Supplement Report FDA Received Date: 04/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention