FDA Adverse Event Malfunction Summary report: N

ADVANTAGE BALLOON CATHETER INFLATION DEVICE

MDR report key: 1781664 · Received August 3, 2010

Report

Report Number: 2134265-2010-03241
Event Type: Malfunction
Date Received: August 3, 2010
Date of Event: May 19, 2010
Report Date: July 7, 2010
Manufacturer: BOSTON SCIENTIFIC - CORK
Product Code: MAV
PMA / PMN Number: K955869
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THE TOP OF THE ENCORE UNIT WHICH HOLDS THE GAUGE WAS SPLIT IN TWO. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS MANUFACTURING RELATED AS IT IS PROBABLE THAT THE ENCORE DEVICE DID NOT SNAP TOGETHER AT THE SNAP PRESS STATION PROPERLY AND THE TWO SNAPS DID NOT ALIGN. THIS WOULD CAUSE THE UNIT TO COME APART WHEN PRESSURE IS APPLIED. (B)(4).

Description of Event or Problem · 1

THIS COMPLAINT IS REPORTABLE BASED ON RETURNED DEVICE ANALYSIS COMPLETED ON (B)(6) 2010. IT WAS REPORTED THAT DURING A PERCUTANEOUS INTERVENTION (PCI) PROCEDURE THE OUTER GAUGE HOUSING CRACKED. AN ADVANTAGE 26 KIT HAD BEEN SELECTED FOR USE WITH AN UNSPECIFIED BALLOON. THE ENCORE 26 INFLATION UNIT FROM THE KIT WAS ATTACHED TO THE BALLOON AND WHILE INFLATING THE BALLOON, THE OUTER HOUSING OF THE GAUGE "CRACKED" OPEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME INFLATION DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS OK. RETURNED DEVICE ANALYSIS REVEALED THE GAUGE WAS DETACHED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ADVANTAGE BALLOON CATHETER INFLATION DEVICE	SYRINGE, BALLOON INFLATION	MAV	BOSTON SCIENTIFIC - CORK	H74904527011

Patients

Seq	Age	Sex	Outcome	Treatment
1