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

Catalog Number 025227-OE

Device Problem Occlusion Within Device (1423)

Patient Problem No Code Available (3191)

Event Date 04/07/2016

Event Type  Injury  

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 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.

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
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 5660892
• MDR Text Key: 45338868
• Report Number: 1820334-2016-00316
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002180703
• UDI-Public: (01)00827002180703(17)180830(10)6165223
• Combination Product (y/n): N
• Reporter Country Code: HU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 025227-OE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/07/2016
• Device Age: 8 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/25/2016
• Initial Date FDA Received: 05/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/11/2017
• Date Device Manufactured: 08/30/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention