SABERX RADIANZ
Report
- Report Number
- 3007635982-2023-00012
- Event Type
- Injury
- Date Received
- March 8, 2023
- Date of Event
- February 14, 2023
- Report Date
- June 23, 2023
- Manufacturer
- CORDIS US. CORP
- Product Code
- LIT
- UDI-DI
- 20705032081877
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS DEVICE HAS BEEN ANALYZED BUT THE FINAL, APPROVED DRAFT OF THE ENGINEERING REPORT AND ITS CONCLUSION IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. H3 OTHER TEXT : THIS DEVICE HAS BEEN ANALYZED BUT THE FINAL, APPROVED DRAFT OF THE ENGINEERING REPORT AND ITS CONCLUSION IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
THIS DEVICE IS AVAILABLE FOR ANALYSIS, BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH LOT 82258876 PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED EVENT. THIS DEVICE IS AVAILABLE FOR ANALYSIS, BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS HAVE BEEN UPDATED ACCORDINGLY: B4, G1, G3, G6, H1, H2, H3, H6, AND H10. COMPLAINT CONCLUSION: AS REPORTED, A PROCEDURE TO TREAT A 90% STENOSIS OF THE RIGHT COMMON ILIAC ARTERY (CIA) WAS PERFORMED VIA THE LEFT RADIAL ARTERY. A 5F NON-CORDIS CATHETER SHEATH INTRODUCER (CSI) WAS INSERTED VIA THE LEFT RADIAL ARTERY AND A NON-CORDIS .035 GUIDEWIRE WAS PLACED IN THE ABDOMINAL AORTA WITH AN UNKNOWN PIGTAIL CATHETER. THE 5F NON - CORDIS CSI WAS THEN EXCHANGED FOR A 110CM BRITE TIP RADIANZ CSI. A NON-CORDIS .018 FLOPPY GUIDEWIRE WAS PLACED ACROSS THE LESION AND AN INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED WITH A NON-CORDIS IVUS CATHETER. NEXT, PRE-DILATION WAS PERFORMED WITH AN 8MM X 60MM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER. A 10MM X 60MM SMART RADIANZ SELF-EXPANDING STENT (SES) WAS THEN INSERTED VIA THE LEFT RADIAL ARTERY AND WAS IMPLANTED. DURING IMPLANTATION, THE TANTALUM MARKERS WERE OBSERVED TO OPEN SYMMETRICALLY AND THE STENT WAS FULLY OPPOSED TO THE VESSEL WALL WHEN DEPLOYED. AN IVUS WAS THEN ATTEMPTED WITH THE NON-CORDIS IVUS CATHETER; HOWEVER, THE IVUS CATHETER WAS CAUGHT ON THE PROXIMAL EDGE OF THE IMPLANTED SMART STENT CAUSING THE STENT MARKER EDGE TO BECOME UPLIFTED. THE NON-CORDIS IVUS CATHETER WAS THEN REMOVED AND THE 8MM X 60MM SABERX RADIANZ PTA BALLOON CATHETER WAS USED AGAIN IN AN ATTEMPT TO EXPAND THE PROXIMAL PART OF THE SMART STENT; HOWEVER, THE BALLOON RUPTURED AT 14 ATMOSPHERES (ATM). AN ATTEMPT TO REMOVE THE SABERX RADIANZ BALLOON CATHETER WAS THEN MADE BUT THE BALLOON CATHETER WAS CAUGHT ON THE STENT AND WAS DIFFICULT TO REMOVE. MULTIPLE ATTEMPTS WERE MADE TO PUSH AND PULL THE SABERX RADIANZ BALLOON CATHETER, BUT IT WAS NOT POSSIBLE TO REMOVE. AS A RESULT, A NON-CORDIS .014 GUIDEWIRE WAS INSERTED BETWEEN THE STENT AND THE 8MM X 60MM SABERX RADIANZ PTA BALLOON CATHETER, FOLLOWED BY THE INSERTION OF A 2MM X 4MM NON-CORDIS PTA BALLOON CATHETER. THE NON-CORDIS BALLOON CATHETER WAS EXPANDED AND WAS ABLE TO RELEASE THE 8MM X 60MM SABERX RADIANZ BALLOON FROM THE STENT. HOWEVER, THE SABERX RADIANZ PTA BALLOON CATHETER COULD NOT BE PULLED INTO THE BRITE TIP RADIANZ CSI. BOTH THE SABERX RADIANZ BALLOON CATHETER AND BRITE TIP RADIANZ CSI WERE PULLED BACK INTO THE LEFT RADIAL ARTERY AND THE DEVICES WERE REMOVED AS A UNIT. THE LEFT BRACHIAL AND LEFT RADIAL ARTERIES WERE CHECKED TO CONFIRM THAT THERE IS NO PROBLEM, AND THE PROCEDURE WAS COMPLETED. THE SABERX RADIANZ BALLOON CATHETER WAS ABLE TO BE REMOVED IN ONE PIECE FROM THE PATIENT. THERE WERE NO PATIENT INJURIES DURING THIS PROCEDURE. THERE WAS SEVERE CALCIFICATION AND MODERATE TORTUOSITY PRESENT AT THE TARGET LESION. THE DEVICES WERE STORED, HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS WHEN PREPARING THE 8MM X 60MM SABERX RADIANZ PTA BALLOON CATHETER, AND THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. ADDITIONALLY, THERE WAS NO DAMAGE TO THE BRITE TIP RADIANZ CSI. THE 8MM X 60MM SABERX RADIANZ PTA BALLOON CATHETER WILL BE RETURNED FOR EVALUATION. THE 10MM X 60MM SMART RADIANZ SES DELIVERY SYSTEM WAS DISCARDED AND WILL NOT BE RETURNED. THE DEVICE WAS RETURNED FOR ANALYSIS. ONE NON-STERILE SABERX RADIANZ 8MM X 6CM 190 UNIT WAS RECEIVED COILED FOR ANALYSIS INSIDE A PLASTIC BAG. THE DEVICE WAS UNPACKED TO PROCEED WITH THE PRODUCT EVALUATION. DURING VISUAL INSPECTION, AN UNKNOWN GUIDEWIRE ALREADY INSERTED INTO THE SABER UNIT WAS RETURNED FOR EVALUATION. A BURST WAS NOTED ON THE PROXIMAL SECTION OF THE BALLOON. NO OTHER ANOMALIES WERE OBSERVED. SEM ANALYSIS WAS PERFORMED, AND RESULTS SHOWED THAT THE BURST AREA OF THE BALLOON PRESENTED EVIDENCE OF ELONGATIONS. THE ELONGATIONS FOUND ON THE MATERIAL OF THE UNIT ARE COMMONLY ASSOCIATED WITH SEPARATIONS CAUSED BY MATERIAL TENSILE OVERLOAD. THEREFORE, IT IS ASSUMED THAT THE BALLOON WAS INDUCED TO A TENSILE FORCE THAT EXCEEDED THE MATERIAL YIELD STRENGTH PRIOR TO THE BURST. NO OTHER ANOMALIES WERE OBSERVED DURING THE SEM ANALYSIS. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT 82258876 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE REPORTED ¿BALLOON BURST AT/BELOW RBP¿ WAS CONFIRMED SINCE THE BALLOON WAS RECEIVED RUPTURED. THE REPORTED ¿BALLOON ¿ WITHDRAWAL DIFFICULTY SNAGGED/CAUGHT ON STENT¿ WAS NOT CONFIRMED DUE TO THE NATURE OF THE COMPLAINT AS THE EVENT CANNOT BE REPLICATED IN A LAB. THE REPORTED ¿STENT DAMAGED TANTALUM MARKERS¿ WAS NOT CONFIRMED AS THE DEVICE NOR PROCEDURAL IMAGES WERE PROVIDED IN ORDER TO CONFIRM THE FAILURE TO THE STENT. HOWEVER, RESULTS OF SEM ANALYSIS ON THE BALLOON WERE CONFIRMED TO HAVE A RUPTURED CONDITION ALONG WITH ELONGATIONS WHICH ARE COMMONLY ASSOCIATED WITH SEPARATIONS CAUSED BY MATERIAL TENSILE OVERLOAD. THEREFORE, IT IS ASSUMED THAT THE BALLOON WAS INDUCED TO A TENSILE FORCE THAT EXCEEDED THE MATERIAL YIELD STRENGTH AFTER THE RUPTURE OCCURRED. ADDITIONALLY, IT WAS NOTED THAT DURING THE PROCEDURE OTHER CONCOMITANT DEVICES USED SNAGGED ONTO THE STENT STRUTS AS WELL. BASED ON THE INFORMATION AVAILABLE FOR REVIEW IT IS LIKELY PROCEDURAL AND/OR HANDLING FACTORS CONTRIBUTED TO THE EVENT REPORTED AS EVIDENCED BY DEVICE ANALYSIS. ACCORDING TO THE WARNINGS IN THE SAFETY INFORMATION IN THE INSTRUCTIONS FOR USE, ¿PRIOR TO ANGIOPLASTY, THE CATHETER SHOULD BE EXAMINED TO VERIFY FUNCTIONALITY AND INTEGRITY, AND ENSURE THAT ITS SIZE AND SHAPE ARE SUITABLE FOR THE SPECIFIC PROCEDURE FOR WHICH IT IS TO BE USED. DO NOT USE IF PRODUCT DAMAGE IS SUSPECTED OR EVIDENT. TO REDUCE THE POTENTIAL FOR VESSEL DAMAGE OR THE RISK OF DISLODGEMENT OF PARTICLES IT IS VERY IMPORTANT THAT THE INFLATED DIAMETER OF THE BALLOON SHOULD APPROXIMATE THE DIAMETER OF THE VESSEL JUST PROXIMAL AND DISTAL TO THE LESION. THE BALLOON DIMENSIONS ARE PRINTED ON THE PRODUCT LABEL. THE COMPLIANCE TABLE INCORPORATED WITH THE PRODUCT SHOWS HOW BALLOON DIAMETER INCREASES AS PRESSURE INCREASES. DO NOT EXCEED THE RATED BURST PRESSURE RECOMMENDED ON THE LABEL. THE RATED BURST PRESSURE IS BASED ON THE RESULTS OF IN VITRO TESTING. AT LEAST 99.9% OF THE BALLOONS (WITH A 95% CONFIDENCE) WILL NOT BURST AT OR BELOW THEIR RATED BURST PRESSURE. USE OF A PRESSURE MONITORING DEVICE IS RECOMMENDED TO PREVENT OVER-PRESSURIZATION. PRESSURE IN EXCESS OF THE RATED BURST PRESSURE CAN CAUSE BALLOON RUPTURE AND POTENTIAL INABILITY TO WITHDRAW THE CATHETER THROUGH THE INTRODUCER SHEATH. BALLOON RUPTURE CAN CAUSE VESSEL DAMAGE AND THE NEED FOR ADDITIONAL INTERVENTION. USE ONLY THE RECOMMENDED BALLOON INFLATION MEDIUM (A 50/50 MIXTURE BY VOLUME OF CONTRAST MEDIUM AND NORMAL SALINE). NEVER USE AIR OR ANY GASEOUS MEDIUM TO INFLATE THE BALLOON.¿ NEITHER THE PHR NOR THE INFORMATION AVAILABLE SUGGESTS A DESIGN OR MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENT. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN AT THIS TIME.
AS REPORTED, A PROCEDURE TO TREAT A 90% STENOSIS OF THE RIGHT COMMON ILIAC ARTERY (CIA) WAS PERFORMED VIA THE LEFT RADIAL ARTERY. A 5F NON-CORDIS CATHETER SHEATH INTRODUCER (CSI) WAS INSERTED VIA THE LEFT RADIAL ARTERY AND A NON-CORDIS .035 GUIDEWIRE WAS PLACED IN THE ABDOMINAL AORTA WITH AN UNKNOWN PIGTAIL CATHETER. THE 5F NON - CORDIS CSI WAS THEN EXCHANGED FOR A 110CM BRITE TIP RADIANZ CSI. A NON-CORDIS .018 FLOPPY GUIDEWIRE WAS PLACED ACROSS THE LESION AND AN INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED WITH A NON-CORDIS IVUS CATHETER. NEXT, PRE-DILATION WAS PERFORMED WITH AN 8MM X 60MM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER. A 10MM X 60MM SMART RADIANZ SELF-EXPANDING STENT (SES) WAS THEN INSERTED VIA THE LEFT RADIAL ARTERY AND WAS IMPLANTED. DURING IMPLANTATION, THE TANTALUM MARKERS WERE OBSERVED TO OPEN SYMMETRICALLY AND THE STENT WAS FULLY OPPOSED TO THE VESSEL WALL WHEN DEPLOYED. AN IVUS WAS THEN ATTEMPTED WITH THE NON-CORDIS IVUS CATHETER; HOWEVER, THE IVUS CATHETER WAS CAUGHT ON THE PROXIMAL EDGE OF THE IMPLANTED SMART STENT CAUSING THE STENT MARKER EDGE TO BECOME UPLIFTED. THE NON-CORDIS IVUS CATHETER WAS THEN REMOVED AND THE 8MM X 60MM SABERX RADIANZ PTA BALLOON CATHETER WAS USED AGAIN IN AN ATTEMPT TO EXPAND THE PROXIMAL PART OF THE SMART STENT; HOWEVER, THE BALLOON RUPTURED AT 14 ATMOSPHERES (ATM). AN ATTEMPT TO REMOVE THE SABERX RADIANZ BALLOON CATHETER WAS THEN MADE BUT THE BALLOON CATHETER WAS CAUGHT ON THE STENT AND WAS DIFFICULT TO REMOVE. MULTIPLE ATTEMPTS WERE MADE TO PUSH AND PULL THE SABERX RADIANZ BALLOON CATHETER, BUT IT WAS NOT POSSIBLE TO REMOVE. AS A RESULT, A NON-CORDIS .014 GUIDEWIRE WAS INSERTED BETWEEN THE STENT AND THE 8MM X 60MM SABERX RADIANZ PTA BALLOON CATHETER, FOLLOWED BY THE INSERTION OF A 2MM X 4MM NON-CORDIS PTA BALLOON CATHETER. THE NON-CORDIS BALLOON CATHETER WAS EXPANDED AND WAS ABLE TO RELEASE THE 8MM X 60MM SABERX RADIANZ BALLOON FROM THE STENT. HOWEVER, THE SABERX RADIANZ PTA BALLOON CATHETER COULD NOT BE PULLED INTO THE BRITE TIP RADIANZ CSI. BOTH THE SABERX RADIANZ BALLOON CATHETER AND BRITE TIP RADIANZ CSI WERE PULLED BACK INTO THE LEFT RADIAL ARTERY AND THE DEVICES WERE REMOVED AS A UNIT. THE LEFT BRACHIAL AND LEFT RADIAL ARTERIES WERE CHECKED TO CONFIRM THAT THERE IS NO PROBLEM, AND THE PROCEDURE WAS COMPLETED. THE SABERX RADIANZ BALLOON CATHETER WAS ABLE TO BE REMOVED IN ONE PIECE FROM THE PATIENT. THERE WERE NO PATIENT INJURIES DURING THIS PROCEDURE. THERE WAS SEVERE CALCIFICATION AND MODERATE TORTUOSITY PRESENT AT THE TARGET LESION. THE DEVICES WERE STORED, HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS WHEN PREPARING THE 8MM X 60MM SABERX RADIANZ PTA BALLOON CATHETER, AND THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. ADDITIONALLY, THERE WAS NO DAMAGE TO THE BRITE TIP RADIANZ CSI. THE DEVICES WILL BE RETURNED FOR EVALUATION.
AS REPORTED, A PROCEDURE TO TREAT A 90% STENOSIS OF THE RIGHT COMMON ILIAC ARTERY (CIA) WAS PERFORMED VIA THE LEFT RADIAL ARTERY. A 5F NON-CORDIS CATHETER SHEATH INTRODUCER (CSI) WAS INSERTED VIA THE LEFT RADIAL ARTERY AND A NON-CORDIS .035 GUIDEWIRE WAS PLACED IN THE ABDOMINAL AORTA WITH AN UNKNOWN PIGTAIL CATHETER. THE 5F NON - CORDIS CSI WAS THEN EXCHANGED FOR A 110CM BRITE TIP RADIANZ CSI. A NON-CORDIS .018 FLOPPY GUIDEWIRE WAS PLACED ACROSS THE LESION AND AN INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED WITH A NON-CORDIS IVUS CATHETER. NEXT, PRE-DILATION WAS PERFORMED WITH AN 8MM X 60MM SABERX RADIANZ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER. A 10MM X 60MM SMART RADIANZ SELF-EXPANDING STENT (SES) WAS THEN INSERTED VIA THE LEFT RADIAL ARTERY AND WAS IMPLANTED. DURING IMPLANTATION, THE TANTALUM MARKERS WERE OBSERVED TO OPEN SYMMETRICALLY AND THE STENT WAS FULLY OPPOSED TO THE VESSEL WALL WHEN DEPLOYED. AN IVUS WAS THEN ATTEMPTED WITH THE NON-CORDIS IVUS CATHETER; HOWEVER, THE IVUS CATHETER WAS CAUGHT ON THE PROXIMAL EDGE OF THE IMPLANTED SMART STENT CAUSING THE STENT MARKER EDGE TO BECOME UPLIFTED. THE NON-CORDIS IVUS CATHETER WAS THEN REMOVED AND THE 8MM X 60MM SABERX RADIANZ PTA BALLOON CATHETER WAS USED AGAIN IN AN ATTEMPT TO EXPAND THE PROXIMAL PART OF THE SMART STENT; HOWEVER, THE BALLOON RUPTURED AT 14 ATMOSPHERES (ATM). AN ATTEMPT TO REMOVE THE SABERX RADIANZ BALLOON CATHETER WAS THEN MADE BUT THE BALLOON CATHETER WAS CAUGHT ON THE STENT AND WAS DIFFICULT TO REMOVE. MULTIPLE ATTEMPTS WERE MADE TO PUSH AND PULL THE SABERX RADIANZ BALLOON CATHETER, BUT IT WAS NOT POSSIBLE TO REMOVE. AS A RESULT, A NON-CORDIS .014 GUIDEWIRE WAS INSERTED BETWEEN THE STENT AND THE 8MM X 60MM SABERX RADIANZ PTA BALLOON CATHETER, FOLLOWED BY THE INSERTION OF A 2MM X 4MM NON-CORDIS PTA BALLOON CATHETER. THE NON-CORDIS BALLOON CATHETER WAS EXPANDED AND WAS ABLE TO RELEASE THE 8MM X 60MM SABERX RADIANZ BALLOON FROM THE STENT. HOWEVER, THE SABERX RADIANZ PTA BALLOON CATHETER COULD NOT BE PULLED INTO THE BRITE TIP RADIANZ CSI. BOTH THE SABERX RADIANZ BALLOON CATHETER AND BRITE TIP RADIANZ CSI WERE PULLED BACK INTO THE LEFT RADIAL ARTERY AND THE DEVICES WERE REMOVED AS A UNIT. THE LEFT BRACHIAL AND LEFT RADIAL ARTERIES WERE CHECKED TO CONFIRM THAT THERE IS NO PROBLEM, AND THE PROCEDURE WAS COMPLETED. THE SABERX RADIANZ BALLOON CATHETER WAS ABLE TO BE REMOVED IN ONE PIECE FROM THE PATIENT. THERE WERE NO PATIENT INJURIES DURING THIS PROCEDURE. THERE WAS SEVERE CALCIFICATION AND MODERATE TORTUOSITY PRESENT AT THE TARGET LESION. THE DEVICES WERE STORED, HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS WHEN PREPARING THE 8MM X 60MM SABERX RADIANZ PTA BALLOON CATHETER, AND THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION. ADDITIONALLY, THERE WAS NO DAMAGE TO THE BRITE TIP RADIANZ CSI. THE 8MM X 60MM SABERX RADIANZ PTA BALLOON CATHETER WILL BE RETURNED FOR EVALUATION. THE 10MM X 60MM SMART RADIANZ SES DELIVERY SYSTEM WAS DISCARDED AND WILL NOT BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 124477 | SABERX RADIANZ | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL | LIT | CORDIS US. CORP | R51008006L | 82258876 | 20705032081877 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention | .035 RADIOFOCUS GUIDEWIRE| .035 RADIOFOCUS GUIDEWIRE| .035 RADIOFOCUS GUIDEWIRE| .035 RADIOFOCUS GUIDEWIRE| 2MM 40MM ULTRAVERSE BALLOON CATHETER| 2MM 40MM ULTRAVERSE BALLOON CATHETER| 2MM 40MM ULTRAVERSE BALLOON CATHETER| 2MM 40MM ULTRAVERSE BALLOON CATHETER| 5F TERUMO CSI| 5F TERUMO CSI| 5F TERUMO CSI| 5F TERUMO CSI| IVUS CATHETER (BOSTON SCIENTIFIC)| IVUS CATHETER (BOSTON SCIENTIFIC)| IVUS CATHETER (BOSTON SCIENTIFIC)| IVUS CATHETER (BOSTON SCIENTIFIC)| VASSALLO GT 14 GUIDEWIRE| VASSALLO GT 14 GUIDEWIRE| VASSALLO GT 14 GUIDEWIRE| VASSALLO GT 14 GUIDEWIRE| VASSALLO GT 18 FLOPPY GUIDEWIRE| VASSALLO GT 18 FLOPPY GUIDEWIRE| VASSALLO GT 18 FLOPPY GUIDEWIRE| VASSALLO GT 18 FLOPPY GUIDEWIRE |