FDA Adverse Event Malfunction Summary report: N

ARROW CVC SET: 2-LUMEN 7 FR X 20 CM

MDR report key: 8621160 · Received May 17, 2019

Report

Report Number: 3006425876-2019-00325
Event Type: Malfunction
Date Received: May 17, 2019
Date of Event: April 6, 2019
Report Date: May 2, 2019
Manufacturer: ARROW INTERNATIONAL INC.
Product Code: DQY
PMA / PMN Number: K862056
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TW
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE CUSTOMER REPORT OF A KINKED GUIDE WIRE WAS CONFIRMED BASED ON VISUAL EXAMINATION OF THE CUSTOMER SUPPLIED PHOTOS. HOWEVER, COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED , AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE, THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. THE IFU PROVIDED WITH THIS KIT WARNS THE USER, "DO NOT CUT SPRING-WIRE GUIDE TO ALTER LENGTH. DO NOT WITHDRAW SPRING-WIRE GUIDE AGAINST NEEDLE BEVEL TO MINIMIZE THE RISK OF POSSIBLE SEVERING OR DAMAGING OF SPRING-WIRE GUIDE. " TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

Description of Event or Problem · 1

THE CUSTOMER REPORTS: THE DOCTOR FELT NOT SMOOTH WHEN INSERTING GUIDEWIRE INTO PATIENT, AND THE GUIDEWIRE WAS KINKED AFTER PULLING OUT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
413292	ARROW CVC SET: 2-LUMEN 7 FR X 20 CM	CATHETER PERCUTANEOUS	DQY	ARROW INTERNATIONAL INC.		71F18C2000

Patients

Seq	Age	Sex	Outcome	Treatment
1