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

Catalog Number UNKNOWN

Device Problem Material Separation (1562)

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

Event Type  Injury  

Manufacturer Narrative

Date of report: unknown as not provided.Catalog and lot # unknown as not provided.(b)(4).The event is currently under investigation.

Event Description

During the placement of the stent through a cystoscope, the stent sheared and half the tether was inside the patient and half was outside of the patient.Its unknown how the procedure was completed.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).A review of the complaint history, documentation, specifications, instructions for use (ifu), and trends was conducted during the investigation.The device is shipped with an instruction for use (ifu) that cautions the user not to force components during removal or replacement.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.It is possible that the user exerted too much force while removing the stent.However, based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the quality engineering risk assessment (qera) no further action is required.

Event Description

During the placement of the stent through a cystoscope, the stent sheared and half the tether was inside the patient and half was outside of the patient.Its unknown how the procedure was completed.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

• Brand Name: UNKNOWN
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 5669633
• MDR Text Key: 45650552
• Report Number: 1820334-2016-00333
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961446
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/27/2016

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/02/2016
• Initial Date FDA Received: 05/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/12/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other