MAUDE Adverse Event Report: COOK INC BANDER URETERAL DIVERSION STENT SET; FAD STENT, URETERAL

Catalog Number	025227-OE
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/07/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pt identifier) unknown as not provided.Age at time of event, date of birth) unknown as not provided.Weight) unknown as not provided.(b)(4).The event is currently under investigation.
Event or Problem Description
The female patient had the ureteral stent placed on (b)(6) 2016.The procedure went well.After two days they realized that the stent had been engorged by litho-problems.The user facility removed the stent and had to re-operate on the patient.When the doctor re-opened the patient, he decided to use another manufacturer's catheter.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The patient is reported to be doing well.
Additional Manufacturer Narrative
Investigation - evaluation a review of the complaint history, device history record, quality control, and specification of the device was conducted during the investigation.Device was not returned for investigation.There is no indication that a design or process related failure mode contributed to this event.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.A review of device history record did not observe any nonconformance that may have contributed to this incident.Based on the provided information a definitive root cause cannot be established or reported at this time.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: BANDER URETERAL DIVERSION STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5660892
• Report Number: 1820334-2016-00316
• Device Sequence Number: 13457945
• Product Code: FAD
• UDI-Device Identifier: 00827002180703
• UDI-Public: (01)00827002180703(17)180830(10)6165223
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2017

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: 025227-OE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/07/2016
• Device Age: 8 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/17/2016
• Supplement Report FDA Received Date: 05/11/2017
• 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