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

Catalog Number UNKNOWN

Device Problems Break (1069); 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, ¿this is regarding a cook medical ureteral stent that was placed in 2017.This patient gets stents replaced every 3 months or so.She came into the urology department in 2017 to have the stents removed and replaced.Both stents were found to be broken in half upon removal with both ureters containing pieces of the retained stent.Another ureteral stent was able to be inserted anyway so that the patient's urinary status was not compromised.A future surgery was scheduled to remove the broken pieces".This report is being filed to capture the reported breakage of the left ureteral stent.Mfr.Report #1820334-2017-02873 has been filed to capture the reported breakage of the right ureteral stent.As reported, pieces of the stents remained in the patient¿s ureters.Surgical intervention is required to retrieve the pieces that remain.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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: UNKNOWN
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6864915
• MDR Text Key: 86127811
• Report Number: 1820334-2017-02872
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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

• 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
• Initial Date Manufacturer Received: 09/05/2017
• Initial Date FDA Received: 09/14/2017
• Supplement Dates Manufacturer Received: 02/01/2018
• Supplement Dates FDA Received: 03/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention