NC SPRINTER RX

Report

Report Number: 9612164-2013-00315
Event Type: Malfunction
Date Received: March 20, 2013
Date of Event: February 8, 2013
Report Date: February 25, 2013
Manufacturer: MEDTRONIC MEXICO
Product Code: LOX
PMA / PMN Number: P790017
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

RESULTS: PRESENCE OF CALCIFICATION INSIDE THE VESSEL HAS MOST LIKELY CONTRIBUTED TO THE BALLOON DAMAGE AND LEAK. RADIAL TEAR, CHATTER MARKS, DISTAL TIP WAS DAMAGED. CONCLUSION: PRESENCE OF CALCIFICATION INSIDE THE VESSEL HAS MOST LIKELY CONTRIBUTED TO THE BALLOON DAMAGE AND LEAK. (B)(4).

Description of Event or Problem · 1

THE PHYSICIAN WAS ATTEMPTING TO PRE-DILATE THE CIRCUMFLEX LESION WITH A NC SPRINTER BALLOON. NO ABNORMALITY WAS NOTED DURING PREPARATION OF THE DEVICE, HOWEVER, THE SPRINTER WOULD NOT INFLATE BEYOND 2 ATM LOSING PRESSURE IMMEDIATELY. A NUMBER OF UNSUCCESSFUL ATTEMPTS WERE CARRIED OUT TO INFLATE THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER NC BALLOON AND STENTING. NO CLINICAL SEQUELAE REPORTED. EVALUATION SUMMARY: THE BALLOON HAD BEEN PARTIALLY INFLATED. THE DISTAL TIP WAS DAMAGED. HARDENED CONTRAST AND BLOOD WERE PRESENT INSIDE THE INFLATION LUMEN AND BALLOON. THE DEVICE WAS PLACED IN A 37 DEGREE CELSIUS WATERBATH FOR 24 HOURS TO SOFTEN THE CONTRAST AND BLOOD TO FACILITATE BALLOON INFLATION. THE DEVICE FAILED NEGATIVE PREP. PRESSURE WAS APPLIED TO THE DEVICE AND LIQUID WAS SEEN EXITING THE DISTAL BALLOON CONE. A SMALL RADIAL TEAR WAS LOCATED ON THE DISTAL BALLOON CONE. CHATTER MARKS WERE PRESENT ON THE DISTAL CONE RUNNING INTO THE RADIAL TEAR FROM THE DISTAL SIDE OF THE TEAR. METHYLENE BLUE TEST CONFIRMED THAT THE TEAR WAS LOCATED ON TOP OF A FOLD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
116377	NC SPRINTER RX	CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS	LOX	MEDTRONIC MEXICO		206297293

Patients

Seq	Age	Sex	Outcome	Treatment
1