FDA Adverse Event Malfunction Summary report: N

COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET

MDR report key: 24952689 · Received April 22, 2026

Report

Report Number: 3002808486-2026-00070
Event Type: Malfunction
Date Received: April 22, 2026
Date of Event: March 3, 2026
Report Date: April 22, 2026
Manufacturer: WILLIAM COOK EUROPE
Product Code: DTK
UDI-DI: 00827002345041
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MX
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

MANUFACTURERS REF#: (B)(4). G4) SIMILAR TO DEVICE MARKETED UNDER 510(K)/PMA: K233680. INVESTIGATION IS STILL IN PROGRESS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR 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

DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE FOLLOWING REPORT WAS MADE REGARDING A MEDICAL DEVICE, CELECT PLATINUM VENA CAVA FILTER, LOT: E4763372. DUE TO A MALFUNCTION OF THE TRIGGER, WHICH PREVENTED THE PROPER DEPLOYMENT OF THE RELEASE HOOK, THE DEVICE WAS RECOVERED. THE MEDICAL DEVICE, LOT: E4763372, WAS TESTED ON THE OPERATING TABLE. IT WAS CONFIRMED THAT THE HOOK WAS ONLY PARTIALLY RELEASED AND JAMMED AFTER THE TRIGGER WAS PRESSED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
547365	COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET	DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR	DTK	WILLIAM COOK EUROPE	G34504	E4763372	00827002345041

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Male