MAUDE Adverse Event Report: COOK INC UNIVERSA SOFT URETERAL STENT SET

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The stent migrated distally on a patient.The stent was replaced using another of the same device.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Investigation - evaluation a review of the specifications, manufacturing instructions and quality control was conducted during the investigation.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.The lot number of the device is not known; accordingly a review of the device history record could not be conducted.Based on the information provided and results of the investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment no further action is required.Monitoring for similar complaints will continue.

• Brand Name: UNIVERSA SOFT URETERAL STENT SET
• 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: 6132344
• MDR Text Key: 61082942
• Report Number: 1820334-2016-01390
• 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: 11/04/2016
• Initial Date FDA Received: 11/29/2016
• Supplement Dates Manufacturer Received: 08/31/2017
• Supplement Dates FDA Received: 09/01/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention