FDA Adverse Event Injury Summary report: N

UNKNOWN

MDR report key: 21111483 · Received January 9, 2025

Report

Report Number: 3002808486-2025-00003
Event Type: Injury
Date Received: January 9, 2025
Date of Event: November 18, 2024
Report Date: January 9, 2025
Manufacturer: WILLIAM COOK EUROPE
Product Code: DTK
Report Source: Manufacturer report
Reporter Location: MD, US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

MANUFACTURERS REF# (B)(4). BASED ON THE VERY LIMITED INFORMATION REGARDING EVENT AND PATIENT OUTCOME AND AS NO INFORMATION INDICATES DEVICE DEFICIENCY, THIS PR# IS CONSIDERED NOT REPORTABLE IF UNDER INVESTIGATION ADDITIONAL INFORMATION CONFIRM OTHERWISE, THE EVENT WILL BE REASSESSED. G4) PMA/510(K): K233680 CORRECTED DATA COMPARED WITH MEDWATCH REPORT: MW5162754. B4 - 19NOV2024 D3 - COOK MEDICAL LLC E1 - (B)(6). INVESTIGATION IS STILL IN PROGRESS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21CFR 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 FDA MEDWATCH FORM: IVC FILTER PLACED OVER 10 YEARS AGO, REMOVED 2024. RESULTED IN PSEUDOANEURYSM AND RETROPERITONEAL HEMATOMA.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
379288	UNKNOWN	DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR	DTK	WILLIAM COOK EUROPE	UNKNOWN	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	76 YR	Female