MAUDE Adverse Event Report: COOK INC UNKNOWN; FAD STENT, URETERAL

Model Number N/A

Device Problem Material Separation (1562)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

It was reported a stent broke off in a patient on an unknown date in (b)(6), assumed to be 2016.Reportedly approximately two weeks ago in a "very difficult case" the physician was able to remove the retained fragment.An additional procedure was required to remove the fragment from the breakage no additional information was available at the time of this report.

Manufacturer Narrative

Investigation ¿ evaluation: the stent was not returned for analysis and there were no photographs provided; therefore, a physical investigation could not be performed.Without the part number, lot number or the returned device a specific root cause cannot be determined.The lot number was not provided therefore a review of the device history record was unable to be performed.If the device and lot number information are received a review of complaint history for related complaints will be reviewed.No information or materials have been received that will allow comprehensive investigation of this complaint.Per the quality engineering risk assessment; without the product information, the need for corrective actions is not able to be determined.Cook medical has notified the appropriate personnel and the will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: UNKNOWN
• 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: 6190316
• MDR Text Key: 62853699
• Report Number: 1820334-2016-01620
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/01/2017

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 Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2016
• Initial Date FDA Received: 12/20/2016
• Supplement Dates Manufacturer Received: 08/30/2017
• Supplement Dates FDA Received: 09/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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