CROSSER RECANALIZATION CATHETER

Report

Report Number: 2020394-2011-00054
Event Type: Injury
Date Received: March 18, 2011
Date of Event: February 23, 2011
Report Date: February 23, 2011
Manufacturer: BARD PERIPHERAL VASCULAR, INC.
Product Code: DQY
PMA / PMN Number: K072776
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KY, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE LOT NUMBER FOR THE DEVICE WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THE LOT MET ALL RELEASE CRITERIA. THE SAMPLE WILL BE RETAINED BY THE USER FACILITY RISK MANAGEMENT DEPARTMENT. THEREFORE, A SAMPLE EVALUATION COULD NOT BE PERFORMED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

Description of Event or Problem · 1

IT WAS REPORTED THAT A .014 INCH GUIDEWIRE BECAME ENTANGLED ON THE RECANALIZATION CATHETER WHILE THE DEVICES WERE BEING USED TO TREAT A CTO IN THE POSTERIOR TIBIAL ARTERY. REPORTEDLY, THE RECANALIZATION CATHETER COULD NOT BE RETRACTED FROM THE GUIDEWIRE DUE TO THE ENTANGLEMENT. BOTH THE CATHETER AND THE GUIDEWIRE WERE SIMULTANEOUSLY REMOVED. UPON REMOVAL, A HEMATOMA WAS OBSERVED JUST DISTAL TO THE ACCESS SITE IN THE FEMORAL REGION. A LACERATION WAS THEN IDENTIFIED WITHIN THE FEMORAL ARTERY, JUST DISTAL TO THE ACCESS SITE. THE 6F SHEATH WAS REMOVED AND A 9F INTRODUCER SHEATH WAS INSERTED. COMPRESSION WAS HELD IN ATTEMPT TO STOP THE BLEEDING. DESPITE COMPRESSION BEING HELD FOR SEVERAL MINUTES, THE BLEEDING PERSISTED. THE PATIENT WAS THEN SENT TO SURGERY, WHERE ADDITIONAL INTERVENTION WAS PERFORMED TO STOP THE BLEEDING. PATIENT OUTCOME PENDING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CROSSER RECANALIZATION CATHETER		DQY	BARD PERIPHERAL VASCULAR, INC.		33607

Patients

Seq	Age	Sex	Outcome	Treatment
1	81 YR		Required Intervention