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

Catalog Number UNKNOWN

Device Problems Fracture (1260); Material Separation (1562)

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

Event Date 05/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

The fda provided a voluntary medwatch report which stated, ¿patient had regular ureteral stent placements.Stents placed in 2017.Patient had a regularly scheduled visit for a procedure to remove and replace the stents.Per md documentation, right ureteral stent was grasped and removed completely.The stent had fractured at the mid-portion but the entire length was removed.The left ureteral stent proximal curl was fractured off the distal curl and ureteral portion.Patient underwent surgery on the same day in 2017 to remove the left stent portion that was retained.Stents were 6fr x 22 cm double-j ureteral stent".This report is being filed to capture the reported failure of the left ureteral stent.Mfr.Report #1820334-2017-02869 has been filed to capture the reported failure of the right ureteral stent.Patient status unknown as information not provided by reporter.

Manufacturer Narrative

A review of quality control data was conducted during the investigation.The complaint device was not returned; therefore, device failure analysis and physical examination of the device used in this case could not be performed.A 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 device history record review could not be performed as the complaint lot number was not provided.Based on the provided information, no product returned and the investigation, a definitive root cause cannot be established or reported at this time.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: STENT
• 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: 6864540
• MDR Text Key: 86119163
• Report Number: 1820334-2017-02870
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention