FDA Adverse Event Injury Summary report: N

BANDER URETERAL DIVERSION STENT SET

MDR report key: 17126090 · Received June 14, 2023

Report

Report Number: 1820334-2023-00745
Event Type: Injury
Date Received: June 14, 2023
Report Date: June 14, 2023
Manufacturer: COOK INC
Product Code: FAD
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. D2: PRODUCT CODES = FAD, LJE E1: CUSTOMER POSTAL CODE = J1H 5N4 E1: EMAIL: (B)(6). E3: CUSTOMER OCCUPATION = UNKNOWN G4: PMA/510(K) NUMBER = K181971 THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

Description of Event or Problem · 0

AS REPORTED, THE 'BANDER URETERAL DIVERSION STENT SET' DEVICES EASILY OBSTRUCT MAKING IT HARD TO WITHDRAW OVER A GUIDEWIRE. IT WAS REPORTED THAT THIS CAN CAUSE ISSUES SUCH AS LOSING ACCESS AND/OR THE NEED TO PLACE ANOTHER DEVICE PERCUTANEOUSLY IN THE ANGIO SUITE. THESE ISSUES HAVE OCCURRED OVER SEVERAL MONTHS AND NO PRODUCT INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1874996	BANDER URETERAL DIVERSION STENT SET	FAD STENT, URETERAL	FAD	COOK INC		UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown	Required Intervention