MAUDE Adverse Event Report: COOK INC UNIVERSA SOFT URETERAL STENT SET; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number	UNKNOWN
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/16/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
The device was placed on (b)(6) 2016.On (b)(6) 2016, a new intervention was performed for removal of a kidney stone under reno fibroscopy.During, the procedure the device separated into 2 pieces.One portion migrated into the kidney and the other into the bladder.Additional information has been requested.However, it was not provided at the time of this report.
Additional Manufacturer Narrative
*update* additional information provided confirmed the complaint device as a usi-628-rpc-lp, which is not manufactured by cook inc.Therefore, we kindly request that 1820334-2016-00243 be canceled.
Event or Problem Description
The device was placed on (b)(6) 2016.On (b)(6) 2016, a new intervention was performed for removal of a kidney stone under reno fibroscopy.During, the procedure the device separated into 2 pieces.One portion migrated into the kidney and the other into the bladder.*update* additional information provided confirmed the complaint device as a usi-628-rpc-lp, which is not manufactured by cook inc.Therefore, we kindly request that 1820334-2016-00243 be cancelled.

• Brand Name: UNIVERSA SOFT URETERAL STENT SET
• Common Device Name: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5611135
• Report Number: 1820334-2016-00243
• Device Sequence Number: 13497853
• Product Code: FOZ
• UDI-Device Identifier: 00827002148093
• UDI-Public: (01)00827002148093(17)181002(10)6255351
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2016

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/16/2016
• Device Age: 5 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/27/2016
• Supplement Report FDA Received Date: 10/07/2016
• 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: Other