SYNCHRO .014 GUIDEWIRE

MDR report key: 898491 · Received August 16, 2007

Report

Report Number: 6000078-2007-00211
Event Type: Injury
Date Received: August 16, 2007
Date of Event: July 27, 2007
Report Date: July 30, 2007
Manufacturer: BOSTON SCIENTIFIC CORP. / NEUROCASCULAR DIVISION
Product Code: DQX
PMA / PMN Number: K032146
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

K023700, K002907.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN NOTICED GREEN PARTICLES AND "SOME TYPE OF MUCUS" FLOATING IN A BOWL USED TO SOAK DEVICES [INCLUDING THE DEVICE IN QUESTION]. THIS BOWL CONTAINED 1.5L STERILE WATER WITH AN ADDED 6000U OF HEPARIN. THIS GUIDEWIRE WAS REMOVED FROM THE SOLUTION AND WIPED WITH STERILE GAUZE. IT WAS THEN NOTED THAT SOME OF THE COATING HAD COME OFF THE WIRE AND SOME GREEN MATERIAL WAS TRANSFERRED TO THE GAUZE. CONTINUOUS FLUSH WAS MAINTAINED THROUGHOUT THE PROCEDURE AND THE PHYSICIAN IS UNCERTAIN IF ANY OF THIS OBSERVED MATERIAL ENTERED THE PT. THE PT SUFFERED A SMALL INFARCT. THE PHYSICIAN HAS QUESTIONED WHETHER THIS MAY HAVE BEEN CAUSED BY THE PRIOR BALLOON REMODELING PROCEDURE OR PERHAPS MAY BE ATTRIBUTABLE TO THE MUCOUS PARTICULATE MATTER. THE PT IS REPORTED TO BE RECOVERING WELL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SYNCHRO .014 GUIDEWIRE	(DXQ) GUIDEWIRE	DQX	BOSTON SCIENTIFIC CORP. / NEUROCASCULAR DIVISION	1301	B10993

Patients

Seq	Age	Sex	Outcome	Treatment
1	59 YR		Hospitalization