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

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hematoma (1884)

Event Date 04/08/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The (b)(6) male patient with pre-existing condition of bilateral biliary lithiasis had a bilateral double j catheter placement.The patient developed perirenal hematoma that required nephrectomy.

Manufacturer Narrative

(b)(4).Investigation / evaluation: no product was returned; therefore, no physical examinations could be performed.However, during the course of investigation, a review of documentation, drawing, instructions for use (ifu) manufacturing instructions and quality control was conducted.An instruction for use is provided that contains cautions for use.Specifically, it cautions ¿do not force components during removal or replacement.¿ ¿individual variations of interaction between stents and the urinary system are unpredictable.Periodic evaluation via cystoscopic, radiographic, or ultrasonic means is suggested.¿ the device is manufactured per manufacturing instruction and drawing.It is inspected per quality control specification.There is no evidence to suggest the product was not made to specifications.It should be noted that perinephric hematoma is a recognized adverse event from ureteroscopic lithotripsy and pcnl procedures, and not necessarily tied to the device.The appropriate internal personnel will be notified and we will continue to monitor for similar events.No additional risk reduction activity is required.

Event Description

The (b)(6) male patient with pre-existing condition of bilateral biliary lithiasis had a bilateral double j catheter placement.The patient developed perirenal hematoma that required nephrectomy.No information regarding patient outcome has been provided.

• Brand Name: UNIVERSA SOFT URETERAL STENT SET
• 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: 5085420
• MDR Text Key: 26110413
• Report Number: 1820334-2015-00608
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K961446
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/02/2015

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: USH-624
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/08/2015
• Device Age: 8 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR