SYNCHRO-14 NEURO GUIDEWIRE

MDR report key: 911098 · Received September 12, 2007

Report

Report Number: 6000078-2007-00225
Event Type: Malfunction
Date Received: September 12, 2007
Date of Event: September 3, 2007
Report Date: September 3, 2007
Manufacturer: BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIVISION
Product Code: DQX
PMA / PMN Number: K032146
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL PMA/510(K)'S: K023700, K002907.

Description of Event or Problem · 1

THE PATIENT WAS BEING TREATED FOR A SUBARACHNOID HEMORRHAGE AND A RUPTURED ANEURYSM IN THE DISTAL RIGHT POSTERIOR CEREBRAL ARTERY (PCA). THE TARGET VESSEL WAS VERY NARROW, 1-2MM, IN SEVERELY TORTUOUS ANATOMY. THE PHYSICIAN ATTEMPTED TO ADVANCE THE GUIDEWIRE BUT WAS UNABLE TO "FEEL THE DISTAL TIP MOVE". "THE TIP WOULD BE FIXED BY THE VESSEL WALL" WHICH LED THE PHYSICIAN TO BELIEVE A VASOSPASM HAD OCCURRED. THE VASOSPASM COULD NOT BE OBSERVED UNDER FLUOROSCOPY DUE TO THE NARROW VESSEL. AS THE DEVICE WAS BEING WITHDRAWN, REPORTEDLY APPROXIMATELY 35CM OF THE NITINOL HYPOTUBE SEPARATED FROM THE CORE WIRE. THE REMAINDER OF THE GUIDEWIRE WAS REMOVED WITH THE MICROCATHETER. THE PHYSICIAN WAS UNABLE TO ACCESS THE TARGET LESION USING A NON-BOSTON SCIENTIFIC CATHETER AND GUIDEWIRE. THE NITINOL HYPOTUBE WAS NOT REMOVED DUE TO THE PATIENT'S "UNSTABLE CONDITION". THE PROCEDURE WAS THEN TERMINATED IN ORDER TO STABILIZE THE PATIENT. AS OF 2007, THE PATIENT'S CONDITION WAS UNCHANGED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SYNCHRO-14 NEURO GUIDEWIRE	(DQX) GUIDEWIRE	DQX	BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIVISION	1301	B10362

Patients

Seq	Age	Sex	Outcome	Treatment
1	53 YR		Hospitalization	BOSTON SCIENTIFIC EXCELSIOR MICROCATHETER\| BALT MAGIC CATHETER\| EV3 MIRAGE GUIDEWIRE\| CORDIS ENVOY GUIDE CATHETER