MAUDE Adverse Event Report: COOK INC ULTRATHANE AMPLATZ URETERAL STENT SET; FAD STENT, URETERAL

Model Number	N/A
Medical Device Problem Code	Knotted (1340)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma 510k status: preamendment.(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 customer reported that the ultrathane amplatz ureteral stent set failed.Additional information regarding the failure was later received: when the device was removed from the packaging, the string was knotted and not usable.The customer also confirmed that the device did not make any patient contact; accordingly, no patient adverse events were precipitated by the event.The device is reportedly available for return and evaluation; however, as of the date of this report, no device has yet been received for investigation.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable or unchanged.After further review of the event, it was determined that the potential for serious injury is remote as a detailed search of available risk documents has not indicated a heightened patient risk as a result of the reported failure mode.Additionally, a detailed search of current reporting software has not indicated a past precedence setting event.

• Brand Name: ULTRATHANE AMPLATZ URETERAL STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7107819
• Report Number: 1820334-2017-04322
• Device Sequence Number: 19119011
• Product Code: FAD
• UDI-Device Identifier: 00827002097117
• UDI-Public: (01)00827002097117(17)171103(10)5412102
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2018

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: UTSSW-8.5-28-AMP-RH
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/16/2017
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 12/12/2017
• Supplement Report FDA Received Date: 02/06/2018
• Patient Sequence Number: 1