FDA Adverse Event Injury Summary report: N

UNKNOWN

MDR report key: 14444514 · Received May 19, 2022

Report

Report Number: 1820334-2022-00914
Event Type: Injury
Date Received: May 19, 2022
Report Date: May 18, 2022
Manufacturer: COOK INC
Product Code: DTK
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

CUSTOMER (PERSON) NOT PROVIDED, INFORMATION PROVIDED BY MCSWEENEY LANGEVIN LLC. OCCUPATION: NON-HEALTHCARE PROFESSIONAL. INVESTIGATION: FILTER INTERACTS WITH IVC WALL, E.G. PENETRATION/PERFORATION/EMBEDMENT. THIS MAY BE EITHER SYMPTOMATIC OR ASYMPTOMATIC. POTENTIAL CAUSES MAY INCLUDE IMPROPER DEPLOYMENT; AND (OR) EXCESSIVE FORCE OR MANIPULATIONS NEAR AN IN-SITU FILTER (E.G., A SURGICAL OR ENDOVASCULAR PROCEDURE IN THE VICINITY OF A FILTER). POTENTIAL ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: TRAUMA TO ADJACENT STRUCTURES, VASCULAR TRAUMA, VENA CAVA PERFORATION, VENA CAVA PENETRATION. RPN/LOT IS UNKNOWN, HOWEVER, THE DEVICE IS MANUFACTURED AND INSPECTED ACCORDING TO CURRENT CONTROLS. NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS AND NOTHING INDICATES THAT THE FILTER DID NOT PERFORM AS INTENDED, E.G. INTENDED FOR THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PLACEMENT IN THE VENA CAVA. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

Description of Event or Problem · 0

IT IS ALLEGED THAT "PATIENT RECEIVED A COOK TULIP FILTER. PATIENT IS ALLEGING PERFORATION OF IVC. HOSPITAL AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1001653	UNKNOWN	DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR	DTK	COOK INC		UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1		Male	Life Threatening