FDA Adverse Event Malfunction Summary report: N

MAVERICK OVER-THE WIRE BALLOON CATHETER

MDR report key: 1001738 · Received February 19, 2008

Report

Report Number
2134265-2008-00446
Event Type
Malfunction
Date Received
February 19, 2008
Date of Event
January 20, 2008
Report Date
January 21, 2008
Manufacturer
BOSTON SCIENTIFIC
Product Code
LOX
PMA / PMN Number
K934378
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
MO, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH VENTRICULAR TACHYCARDIA AND WAS SENT TO THE CATH LAB WHERE AN EMERGENCY SAPHENOUS VEIN GRAFT (SVG) TO NATIVE VESSEL INTERVENTIONAL PROCEDURE WAS PERFORMED. DURING THE PROCEDURE, DEFLATION DIFFICULTIES WERE ENCOUNTERED. THE 90% STENOSED, MODERATELY CALCIFIED LESION WAS LOCATED IN THE MODERATELY TORTUOUS DISTAL SVG ANASTOMOSIS. IT WAS NOTED THAT THE SVG HAD BEEN PLACED IN A PREVIOUS PROCEDURE TO BYPASS THE RIGHT CORONARY ARTERY (RCA) TO THE POSTERIOR DESCENDING ARTERY (PDA). ACCESS WAS OBTAINED VIA THE LEFT GROIN, AND AN UNSPECIFIED MP2 GUIDE CATHETER WAS PLACED AND ANOTHER MANUFACTURER'S GUIDE WIRE SUCCESSFULLY CROSSED THE LESION. AN INITIAL ANGIOGRAPHY REVEALED THAT THE SVG DEMONSTRATED A VERY SLUGGISH FLOW AT TIMI 1. IN AN EFFORT TO IMPROVE BLOOD FLOW, AN UNSPECIFIED OVER-THE-WIRE 2.5MM X 12MM BALLOON WAS ADVANCED TO LESION AND INFLATED ONCE TO 12 ATMS FOR PRE-DILATION, HOWEVER, THIS EFFORT PROVIDED INADEQUATE FILLING OF THE PDA. THE BALLOON WAS REMOVED AND AN UNSPECIFIED 3MM X 12MM BALLOON WAS ADVANCED TO THE LESION AND INFLATED TO 12 ATMS WHICH AGAIN RESULTED IN INADEQUATE FILLING OF THE PDA. ANOTHER MANUFACTURER'S 2.5MM X 12MM STENT WAS SUCCESSFULLY DEPLOYED AT 14 ATMS IN THE LESION, HOWEVER, FLOW INTO THE PDA REMAINED AT TIMI 2. THE PHYSICIAN PERFORMED THROMBECTOMY UTILIZING ANOTHER MANUFACTURER'S ASPIRATION CATHETER, HOWEVER, THIS EFFORT STILL DID NOT IMPROVE BLOOD FLOW TO THE PDA. ANOTHER MANUFACTURER'S 2.25MM X 8MM STENT WAS SUCCESSFULLY IMPLANTED IN A MID-PDA LESION AND SUBSEQUENT ANGIOGRAPHY REVEALED GREATLY IMPROVED FLOW TO THE NATIVE PDA VESSEL. FOLLOWING STENT PLACEMENT, IT WAS NOTED THAT AN EDGE DISSECTION HAD OCCURRED IMMEDIATELY DISTAL TO THE 2.5MM X 12MM STENT. THE PHYSICIAN SUCCESSFULLY DEPLOYED ANOTHER MANUFACTURER'S 2.5MM X 12MM STENT AT 14 ATMS TO SEAL THE DISSECTION. ANGIOGRAPHY WAS PERFORMED WHICH AGAIN REVEALED POOR FLOW INTO THE VESSEL. A MAVERICK 3MM X 12MM OVER-THE WIRE BALLOON CATHETER WAS ADVANCED AND INFLATED TO 14 ATMS FOR A "LONG INFLATION" TO POST-DILATE THE PREVIOUSLY PLACED STENTS. UPON ATTEMPTING TO DEFLATE THE BALLOON, THE PHYSICIAN REPORTED THAT "THE BALLOON WOULD NOT DEFLATE EASILY", HOWEVER, SLIGHT NEGATIVE PRESSURE WAS ABLE TO BE APPLIED TO THE BALLOON AND FOLLOWING "MUCH STRUGGLE" THE BALLOON WAS ABLE TO BE PARTIALLY DEFLATED AND REMOVED WITH THE SHEATH AND GUIDE WIRE AS A UNIT. A SUBSEQUENT ANGIOGRAM REVEALED THAT THE VESSEL CONTAINED TIMI 3 FLOW INTO THE PDA. FOLLOWING THE PROCEDURE, THE PATIENT WAS NO LONGER IN VENTRICULAR TACHYCARDIA AND HAD A NARROW-COMPLEX RHYTHM. AN INTRA-AORTIC BALLOON PUMP (IABP WAS PLACED UNDER FLUOROSCOPIC GUIDANCE AND THE PROCEDURE WAS COMPLETED. THE PATIENT'S STATUS IS REPORTED AS "OK".

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MAVERICK OVER-THE WIRE BALLOON CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC NA 11174419

Patients

Seq Age Sex Outcome Treatment
1 69 YR 6FR PIGTAIL CATHETER| MINI-VISION 2.25 X 8MM STENT| VOYAGER RX 2.5MM X 12MM| 6FR JR4 CATHETER| VOYAGER OTW 2.5MM X 12MM| 0.035 CORDIS J WIRE| 6FR JL4 CATHETER| 300CM BMW WIRE X2| MINI-VISION 2.5MM X 12MM STENT| 190CM BMW WIRE| 6FR MPAI GUIDE X2