PT2 GUIDE WIRE

Report

Report Number: 2134265-2010-04129
Event Type: Injury
Date Received: September 24, 2010
Date of Event: August 27, 2010
Report Date: August 31, 2010
Manufacturer: BOSTON SCIENTIFIC - MIAMI
Product Code: DQX
PMA / PMN Number: K030617
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. EXAMINATION OF THE DEVICE FOUND THAT APPROXIMATELY 4MM OF THE POLYURETHANE SLEEVE WAS MISSING EXPOSING THE CORE WIRE. UPON CLOSER EXAMINATION OF THE DISTAL SECTION, IT WAS OBSERVED THAT THE METAL RIBBON DETACHED FROM THE CORE WIRE. THE OVERALL LENGTH OF THE WIRE WAS MEASURED AND FOUND TO BE 298CM. FROM THIS MEASUREMENT IT COULD BE DETERMINED THAT APPROXIMATELY 1.21 TO 1.84CM FROM THE DISTAL END DETACHED FROM THE REST OF THE CORE WIRE. SCANNING ELECTRON MICROSCOPE ANALYSIS WAS PERFORMED ON THE SAMPLE. EXAMINATION OF THE RIBBON SURFACE REVEALED NO PRESENCE OF FRACTURE FEATURES. SMEARED MATERIAL WAS NOTED. NO MATERIAL ANOMALIES WERE OBSERVED. ANALYSIS WAS PERFORMED TO DETERMINE PRESENCE OF SOLDER AS TIN (SN). ANALYSIS REVEALED PRESENCE OF SOLDER AS TIN (SN) AT ALL SECTIONS ON BOTH SIDES OF THE FLAT RIBBON. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

Additional Manufacturer Narrative · 1

(B)(4)

Description of Event or Problem · 1

IT WAS REPORTED, VIA USER FACILITY MEDWATCH (B)(4), THAT DURING A CARDIAC CATHETERIZATION TREATMENT PROCEDURE, A GUIDE WIRE TIP FRACTURE OCCURRED. THE PATIENT PRESENTED WITH AT-REST ANGINA. THE PHYSICIAN WAS ATTEMPTING TO PASS THIS 300CM PT2 GUIDE WIRE THROUGH A PREVIOUSLY PLACED 50% RESTENOSED UNKNOWN DRUG ELUTING STENT LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS RIGHT CORONARY ARTERY (RCA). THE VESSEL AROUND THE STENT EDGE WAS KINKED AT THE ORIGIN OF THE STENT, OVERLAPPING THE STENT, AND PRESENTED A SHEPHERDS CROOK SHAPE. THIS PT2 GUIDE WIRE WAS BEING USED AS A BUDDY WIRE. THE PHYSICIAN EXPERIENCED DIFFICULTY ADVANCING THE PT2 GUIDE WIRE AS IT APPEARED TO BE ENTRAPPED AT THE PROXIMAL EDGE OF THE STENT. WHEN THE GUIDE WIRE WAS RETRACTED, A 3 TO 4MM SECTION OF THE GUIDE WIRE TIP BROKE OFF. THE PHYSICIAN ASSUMES THE TIP'S COATING CAME OFF DUE TO THE WIRE BEING STUCK ON THE STENT. A GUIDE CATHETER WAS PLACED FOR VACUUM EXTRACTION OF THE FRACTURED TIP, HOWEVER, DURING PLACEMENT THE TIP DISLODGED AND WAS FOLLOWED UNDER FLUOROSCOPIC GUIDANCE INTO A SUB FOURTH ORDER SIDE BRANCH IN THE ILIAC SYSTEM. ANOTHER MANUFACTURER'S SHEATH WAS LOADED OVER ANOTHER MANUFACTURERS' WIRE AND PLACED IN THE LEFT INTERNAL ILIAC ARTERY. A 4F SNARE WAS DEPLOYED AT THE FRACTURED WIRE TIP, HOWEVER, THE TIP MIGRATED TO A VERY SMALL SIDE BRANCH WHERE IT LODGED. IT WAS FELT TO BE A BENIGN ISSUE IN THIS LOCATION. THE PHYSICIAN DETERMINED THAT NO FURTHER ATTEMPT TO EXTRACT THE FRACTURED TIP WOULD BE MADE DUE TO ITS "INNOCUOUS" LOCATION. THERE WERE NO FURTHER COMPLICATIONS. THE PATIENT WAS STABLE UPON THE COMPLETION OF THE CATHETERIZATION AND WAS TRANSFERRED TO THE FLOOR. THE PATIENT UNDERWENT SURGERY UNRELATED TO THIS EVENT FOR A BYPASS GRAFT DUE TO SOME RESIDUAL ANGINA IN THE RCA. THE PATIENT WAS DISCHARGED 11 DAYS LATER, RESTING COMFORTABLY WITH NO SHORTNESS OF BREATH.

Description of Event or Problem · 1

IT WAS REPORTED, VIA USER FACILITY MEDWATCH #: (B)(4), THAT DURING A CARDIAC CATHETERIZATION TREATMENT PROCEDURE, A GUIDE WIRE TIP FRACTURE OCCURRED. THE PATIENT PRESENTED WITH AT-REST ANGINA. THE PHYSICIAN WAS ATTEMPTING TO PASS THIS 300CM PT2 GUIDE WIRE THROUGH A PREVIOUSLY PLACED 50% RESTENOSED UNKNOWN DRUG ELUTING STENT LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS RIGHT CORONARY ARTERY (RCA). THE VESSEL AROUND THE STENT EDGE WAS KINKED AT THE ORIGIN OF THE STENT, OVERLAPPING THE STENT, AND PRESENTED A SHEPHERDS CROOK SHAPE. THIS PT2 GUIDE WIRE WAS BEING USED AS A BUDDY WIRE. THE PHYSICIAN EXPERIENCED DIFFICULTY ADVANCING THE PT2 GUIDE WIRE AS IT APPEARED TO BE ENTRAPPED AT THE PROXIMAL EDGE OF THE STENT. WHEN THE GUIDE WIRE WAS RETRACTED, A 3 TO 4MM SECTION OF THE GUIDE WIRE TIP BROKE OFF. THE PHYSICIAN ASSUMES THE TIP'S COATING CAME OFF DUE TO THE WIRE BEING STUCK ON THE STENT. A GUIDE CATHETER WAS PLACED FOR VACUUM EXTRACTION OF THE FRACTURED TIP, HOWEVER, DURING PLACEMENT, THE TIP DISLODGED AND WAS FOLLOWED UNDER FLUOROSCOPIC GUIDANCE INTO A SUB FOURTH ORDER SIDE BRANCH IN THE ILIAC SYSTEM. ANOTHER MANUFACTURERS' SHEATH WAS LOADED OVER ANOTHER MANUFACTURERS' WIRE AND PLACED IN THE LEFT INTERNAL ILIAC ARTERY. A 4F SNARE WAS DEPLOYED AT THE FRACTURED WIRE TIP, HOWEVER, THE TIP MIGRATED TO A VERY SMALL SIDE BRANCH WHERE IT LODGED. IT WAS FELT TO BE A BENIGN ISSUE IN THIS LOCATION. THE PHYSICIAN DETERMINED THAT NO FURTHER ATTEMPT TO EXTRACT THE FRACTURED TIP WOULD BE MADE DUE TO ITS' "INNOCUOUS" LOCATION. THERE WERE NO FURTHER COMPLICATIONS. THE PATIENT WAS STABLE UPON THE COMPLETION OF THE CATHETERIZATION AND WAS TRANSFERRED TO THE FLOOR. THE PATIENT UNDERWENT SURGERY UNRELATED TO THIS EVENT FOR A BYPASS GRAFT DUE TO SOME RESIDUAL ANGINA IN THE RCA. THE PATIENT WAS DISCHARGED 11 DAYS LATER, RESTING COMFORTABLY WITH NO SHORTNESS OF BREATH.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PT2 GUIDE WIRE	WIRE, GUIDE, CATHETER	DQX	BOSTON SCIENTIFIC - MIAMI	H74938931042	12873478

Patients

Seq	Age	Sex	Outcome	Treatment
1	86 YR		Required Intervention