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

Catalog Number	UFH-622-RT1
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/06/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Requested but not provided.(b)(4).The event is currently under investigation.
Event or Problem Description
During a bilateral stent placement, the tether stretched and broke inside the patient.Tether was removed from patient using a grasper.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Additional information: a maude report was received and has been attached to this record investigation - evaluation a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), specifications and trends was conducted during the investigation.The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as: cautions the user not to force components during removal or replacement.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.The device history record was reviewed and there was no evidence to indicate this device was not manufactured in accordance to current specifications.There were no nonconforming events which could contribute to this failure mode.However, based on the information provided, and no product returned, the root cause is unable to be determined or reported at this time.It is possible that the user exerted too much force while removing the stent.We continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
During a bilateral stent placement, the tether stretched and broke inside the patient.Tether was removed from patient using a grasper.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

• 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: 5615600
• Report Number: 1820334-2016-00257
• Device Sequence Number: 308332
• Product Code: FAD
• UDI-Device Identifier: 10827002234045
• UDI-Public: (01)10827002234045(17)180730(10)6078388
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K961446
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: UFH-622-RT1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/06/2016
• Device Age: 3 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/28/2016
• Supplement Report FDA Received Date: 10/25/2016
• 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