IAB : 8 FR - 40 CC

MDR report key: 1881139 · Received October 1, 2010

Report

Report Number: 1219856-2010-00693
Event Type: Malfunction
Date Received: October 1, 2010
Date of Event: September 6, 2010
Report Date: September 29, 2010
Manufacturer: ARROW INTL., INC.
Product Code: DSP
PMA / PMN Number: K000729
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KS
Reporter Occupation: UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE MD PUNCTURED THE MALE PT'S LEFT FEMORAL ARTERY & INSERTED A SUPER ARROW-FLEX (SAF) SHEATH WITH DILATOR. THE MD THEN ATTACHED A BLUE ONE-WAY VALVE, VACUUMED A BALLOON CATHETER TWICE INSIDE OF THE TRAY TO WRAP THE BALLOON TIGHTLY, THEN GRASPED THE CATHETER CLOSELY & REMOVED IT FROM THE TRAY HORIZONTALLY PER THE INSTRUCTIONS FOR USE. DURING THE INTRA-AORTIC BALLOON (IAB) CATHETERIZATION, THE BALLOON STOPPED ADVANCING & BECAME STUCK IN THE SAF SHEATH. THE MD TRIED TO ADVANCE THE BALLOON CATHETER, BUT HE COULD NOT PASS IT THROUGH THE SAF SHEATH DUE TO CRITICAL RESISTANCE. AS A RESULT, THE MD HAD TO REMOVE THE SAF SHEATH & BALLOON CATHETER TOGETHER FROM THE PT & OPEN A NEW IAB KT. THE MD USED A NEW SAF SHEATH & BALLOON CATHETER FROM A SECOND IAB KIT & SUCCESSFULLY FINISHED THE CATHETERIZATION. THERE WAS NO EXCESSIVE BLEEDING DURING THE PROCEDURE & IN THE SECOND TRIAL, THE SAME INSERTION SITE (LEFT FEMORAL ARTERY) WAS USED WITH NEW IAB CATHETER. THERE WAS A 10 MINUTES DELAY REPORTED AS A RESULT. THERE WAS NO DEATH OR REPORTED PT COMPLICATIONS & PT IS DOING FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	IAB : 8 FR - 40 CC	INTRA-AORTIC BALLOON PRODUCTS	DSP	ARROW INTL., INC.		NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK