ASAHI ASTATO 30 PERIPHERAL GUIDEWIRE

Report

Report Number: 3003775027-2010-00025
Event Type: Injury
Date Received: October 20, 2010
Date of Event: September 22, 2010
Report Date: September 25, 2010
Manufacturer: ASAHI INTECC CO., LTD.
Product Code: DQX
PMA / PMN Number: K071721
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NJ, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE GUIDEWIRE WAS BROKEN OFF AT APPROX 70 CM FROM TIP END. IT IS PRESUMED THAT THE BENDING FORCE WAS REPEATEDLY APPLIED TO THE GUIDEWIRE SHAFT THAT WAS LOCATED AND BENT IN THE BIFURCATION OF COMMON ILIAC ARTERY, WHEN PHYSICIAN WAS REPEATEDLY PUSHING-PULLING THE GUIDEWIRE IN ORDER TO TRY TO CROSS THE HEAVILY CALCIFIED LESION IN TP-TRUNK, AND THAT THE ACCUMULATED FORCE EXCEEDED THE GUIDEWIRE DESIGN LIMIT WHEN THE SHAFT BREAKAGE OCCURRED.

Description of Event or Problem · 1

TO A HEAVILY CALCIFIED CTO IN THE TIBIAL-PERONEAL TRUNK IN RIGHT LEG, PUNCTURE WAS MADE IN THE LEFT GROIN AND APPROACH WAS MADE UP-AND-OVER THE COMMON ILIAC ARTERY. PHYSICIAN WAS ATTEMPTING TO CROSS A HEAVILY CALCIFIED LESION, AND WAS ON HIS 3RD ASTATO GUIDE WIRE BECAUSE THE PREVIOUS WIRE TIPS HAD BECOME DEFORMED DUE TO MULTIPLE ATTEMPTS TO CROSS CTO. THIRD WIRE ADVANCED THROUGH THE OTHER COMPANY'S SUPPORT CATHETER AND A GUIDING SHEATH. AS HE MADE CONTACT WITH CTO TO CROSS, THE PROXIMAL PORTION OF THE WIRE BROKE OFF IN THE SHEATH AND THE SUPPORT CATHETER. PHYSICIAN MADE SEVERAL ATTEMPTS TO SNARE THE WIRE IN THE SHEATH AND EVENTUALLY WAS SUCCESSFUL. CASE WAS THEN ABORTED AFTER THIS LAST, FAILED ATTEMPT. IT TOOK THE PHYSICIAN ROUGHLY 60 MINUTES TO SNARE THE WIRE AND REMOVE IT FROM THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ASAHI ASTATO 30 PERIPHERAL GUIDEWIRE		DQX	ASAHI INTECC CO., LTD.	NA	03065-17051

Patients

Seq	Age	Sex	Outcome	Treatment
1	66 YR		Hospitalization\| R