FDA Adverse Event Malfunction Summary report: N

STARCLOSE VASCULAR CLOSURER SYSTEM

MDR report key: 1001698 · Received February 15, 2008

Report

Report Number: 2953144-2008-00073
Event Type: Malfunction
Date Received: February 15, 2008
Date of Event: October 17, 2007
Report Date: January 23, 2008
Manufacturer: ABBOTT VASCULAR - VASCULAR SOLUTIONS
Product Code: MGB
PMA / PMN Number: P050007
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS RETURNED WITHOUT THE COMPLETE EXCHANGE SYSTEM, LIMITING THE SCOPE OF THE INVESTIGATION. THE STARCLOSE DEVICE WAS FOUND TO HAVE A BENT CUTTER ASSEMBLY WITH A DAMAGED CUTTING BLADE. NO OTHER DAMAGE TO THE DEVICE WAS DETECTED. THIS TYPE OF DAMAGE IS CONSISTENT WITH IMPROPER TECHNIQUE USED DURING EXCHANGE SYSTEM INSTALLATION. THE ROOT CAUSE FOR THE NOTED ISSUE WAS RELATED TO USER TECHNIQUE ERROR. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS THAT WERE RELEVANT TO THIS INVESTIGATION.

Description of Event or Problem · 1

DEVICE MALFUNCTION: DIFFICULT TO COMPLETE THUMB ADVANCE STROKE. TIME OF MALFUNCTION: DURING VESSEL CLOSURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ARTERIOTOMY CLOSURE OF THE FEMORAL ARTERY WITH THE STARCLOSE AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, THE PHYSICIAN WAS UNABLE TO COMPLETE THE THUMB ADVANCER STEP. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT ISSUE. HEMOSTASIS WAS ACHIEVED WITH MANUAL COMPRESSION. THERE WAS NO REPORT ADVERSE PATIENT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	STARCLOSE VASCULAR CLOSURER SYSTEM		MGB	ABBOTT VASCULAR - VASCULAR SOLUTIONS	NA	55097-6H

Patients

Seq	Age	Sex	Outcome	Treatment
1