FDA Adverse Event Malfunction Summary report: N

PRESSUREWIRE AERIS

MDR report key: 3830244 · Received May 12, 2014

Report

Report Number: 8030904-2014-00007
Event Type: Malfunction
Date Received: May 12, 2014
Date of Event: March 25, 2014
Report Date: April 14, 2014
Manufacturer: ST. JUDE MEDICAL SYSTEMS AB
Product Code: DXO
PMA / PMN Number: K113584
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NE, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

NO EVIDENCE OF EXTERNALLY INDUCED MARKINGS (LIKE SCRATCHING), INHERENT WEAK SPOTS (LIKE INCLUSIONS) OR FLAWS FROM THE MFG PROCESS THAT COULD HAVE CONTRIBUTED TO THE FAILURE WERE FOUND ON THE CORE WIRE. FROM THE VISUAL EXAMINATION AND ANALYSIS OF SEM IMAGES IT IS LIKELY THE FAILURE OCCURRED BY THE EXTENSIVE BENDING FORCE, WHICH INTRODUCED PERMANENT DEFORMATION TO THE MATERIAL. THE WIRE THEN FRACTURED BY A COMBINATION OF TENSILE AND TORSIONAL STRESSES DURING PCI PROCEDURE UNDER DUCTILE FRACTURE MECHANISM. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE DEVICE WAS MANUFACTURED ACCORDING TO SJM SPECIFICATION. IFU TEST EXTRACTS: EXCESSIVE MANIPULATION WHEN SENSOR ELEMENT OR TIP OF PRESSUREWIRE IS LOCATED IN SHARP BEND MAY CAUSE DAMAGE OR TIP FRACTURE, TORQUING PRESSUREWIRE AGAINST RESISTANCE OR REPEATED ATTEMPTS TO CROSS A TOTAL VESSEL OCCLUSION MAY CAUSE DAMAGE AND/OR FRACTURE, WHICH MAY LEAD TO A PORTION OF PRESSUREWIRE SEPARATING FROM THE TIP, NEVER PUSH, WITHDRAW OR TORQUE PRESSUREWIRE IF IT MEETS RESISTANCE.

Description of Event or Problem · 1

DURING A PCI PROCEDURE, THE LESION WAS PASSED AND THE PRESSUREWIRE SEEMED TO GET STUCK. THE PRESSUREWIRE WAS "UNCOILED" AND THE STAFF STRUGGLED GETTING IT OUT OF THE PT. THE PT EXPERIENCED NO ADVERSE CONSEQUENCES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
283305	PRESSUREWIRE AERIS	GUDIEWIRE SENSOR	DXO	ST. JUDE MEDICAL SYSTEMS AB	C12058	4376200

Patients

Seq	Age	Sex	Outcome	Treatment
1