FDA Adverse Event Malfunction Summary report: N

GATEWAY¿

MDR report key: 2781368 · Received October 10, 2012

Report

Report Number: 2939204-2012-00289
Event Type: Malfunction
Date Received: October 10, 2012
Date of Event: September 17, 2012
Report Date: September 17, 2012
Manufacturer: BOSTON SCIENTIFIC - MAPLE GROVE
Product Code: GBA
PMA / PMN Number: H050001
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CN
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS UPON ITS RELEASE. MAGNIFICATION INSPECTION CONFIRMED THAT THE INNER SHAFT WAS APPROPRIATELY SEATED IN THE HUB AND ADHESIVE PRESENT IN THE ADHESIVE CAVITY. MAGNIFIED VIEWS OF THE INNER SHAFT THROUGH THE INFLATION PORT IN THE HUB CONFIRMED THERE WAS A HOLE IN THE INNER SHAFT OF THE CATHETER DIRECTLY ALIGNED WITH THE INFLATION PORT. THE DAMAGE TO THE INNER SHAFT WAS MOST LIKELY DUE TO PERFORATION WITH A NEEDLE OR GUIDEWIRE. NO TOOLS ARE INSERTED IN THE MANIFOLD INFLATION PORT DURING CATHETER ASSEMBLY. FURTHERMORE, ALL DEVICES ARE TESTED FOR BALLOON INFLATION/DEFLATION PERFORMANCE WITH VACUUM DECAY TESTING DURING MANUFACTURE. FROM THE INFORMATION PROVIDED AND THE INVESTIGATION IT WAS DETERMINED THAT HANDLING DAMAGE WAS THE MOST LIKELY CAUSE OF THE REPORTED EVENT.

Description of Event or Problem · 1

DURING PREPARATION, IT WAS FOUND THAT THE BALLOON LEAKED. THERE WAS NO PATIENT INVOLVEMENT.

Description of Event or Problem · 1

DURING PREPARATION, IT WAS FOUND THAT THE BALLOON LEAKED. THERE WAS NO PATIENT INVOLVEMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	GATEWAY¿	CATHETER, BALLOON TYPE	GBA	BOSTON SCIENTIFIC - MAPLE GROVE	M0032072409250	14596695

Patients

Seq	Age	Sex	Outcome	Treatment
1	55 YR