VISTA BRITE TIP
Report
- Report Number
- 9616099-2023-06493
- Event Type
- Injury
- Date Received
- May 15, 2023
- Date of Event
- April 18, 2023
- Report Date
- September 20, 2023
- Manufacturer
- CORDIS US CORP
- Product Code
- DQY
- UDI-DI
- 20705032020854
- PMA / PMN Number
- K021593
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS DEVICE IS AVAILABLE FOR ANALYSIS, BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
COMPLAINT CONCLUSION: AS REPORTED, A 6F .070 100 CM VISTA BRITE TIP XB RCA GUIDING CATHETER WAS FOUND BROKEN INTO MANY PARTS AFTER ONE HOUR OF TRYING TO ROTATE AND CORRECT THE POSITION OF THE GUIDING CATHETER. THE PROXIMAL PART WAS TAKEN OUT SUCCESSFULLY WITH AN UNKNOWN SNARE DEVICE. THE DISTAL PART HAD FLOWN DOWN TO THE ILIAC ARTERY. THE REMOVAL NEEDED VASCULAR SURGERY ASSISTANCE AND IT HAPPENED SUCCESSFULLY IN THE OPERATING ROOM (OR). PATIENT WAS TAKEN TO INTENSIVE CARE AFTER THE PROCEDURE, BUT NO FURTHER COMPLICATION HAPPENED. THE DEVICE WAS PULLED FROM THE PACKAGING BY THE HUB. THE DEVICE WAS TORQUED OR ¿STEERED¿ BY THE HUB. THE CATHETER DID NOT BECOME ENTRAPPED AT ANY POINT IN THE PROCEDURE. THE VESSEL CHARACTERISTICS AT THE TARGET SITE WERE MILD CALCIFICATION, MODERATE TORTUOSITY, AND 99% STENOSIS, NO ACUTE ANGLE OR BIFURCATING. THE VESSEL CHARACTERISTICS AT THE ACCESS SITE WERE MILD CALCIFICATION, MILD TORTUOSITY, NO STENOSIS, ACUTE ANGLE OR BIFURCATING. THE DEVICE WAS USED IN A PATIENT WHO HAD A COMPLEX CORONARY INTERVENTION INVOLVING THE RIGHT CORONARY ARTERY (RCA) WITH A CONTRALATERAL APPROACH USED. THE USER IS THE HEAD OF INTERVENTIONAL CARDIOLOGY DEPARTMENT AND HAS AN EXPERIENCE OF FIFTEEN YEARS IN INTERVENTIONAL CARDIOLOGY WITH PERFORMING MORE THAN FIVE HUNDRED PERCUTANEOUS CORONARY INTERVENTION (PCI) PER YEAR. A NON-STERILE UNIT OF ¿6F .070 XB RCA 100CM¿ WAS RECEIVED FOR EVALUATION. DURING VISUAL ANALYSIS, A SEPARATED CONDITION WAS NOTED. ONLY TWO PIECES WERE RETURNED FOR ANALYSIS. THE OTHER SEGMENTS REPORTED BY THE CUSTOMER WERE NOT RETURNED. THE SEPARATION IS LOCATED APPROXIMATELY 74 CM FROM THE DISTAL TIP. ADDITIONALLY, MULTIPLE KINKS WERE NOTED ALONG THE BODY/SHAFT. AN UNKNOWN GUIDE WIRE WAS RECEIVED STUCK INSIDE THE CATHETER. DIMENSIONAL ANALYSIS COULD NOT BE PERFORMED DUE TO THE EXTENSIVE DAMAGES ON THE CATHETER. SEM ANALYSIS WAS NOT PERFORMED BECAUSE THE DAMAGES ASSOCIATED WITH THE SEPARATION ARE VISIBLE WITH THE MAGNIFICATION OBTAINED WITH A VISION SYSTEM. VISION SYSTEM ANALYSIS OF THE SEPARATED SECTIONS OF THE CATHETER PRESENTED EVIDENCE OF ELONGATIONS ON THE PLASTIC AND PLASTIC DEFORMATION. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT 18072620 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE COMPLAINT REPORTED BY THE CUSTOMER ¿CATHETER (BODY/SHAFT)-SEPARATED¿ WAS CONFIRMED. THE CATHETER WAS RECEIVED SEPARATED. WHILE THE EXACT CAUSE OF THE SEPARATION CANNOT BE CONCLUSIVELY DETERMINED, ELONGATIONS AND PLASTIC DEFORMATIONS ARE COMMONLY ASSOCIATED WITH SEPARATIONS CAUSED BY MATERIAL TENSILE/TWIST OVERLOAD. THEREFORE, IT IS ASSUMED THAT THE MATERIAL WAS INDUCED TO TENSILE/TWIST FORCES THAT EXCEEDED THE MATERIAL YIELD STRENGTH PRIOR TO THE SEPARATION. HANDLING FACTORS SUCH AS TORQUING THE CATHETER EXCESSIVELY WHILE KINKED IS A POSSIBLE UNDERLYING CAUSE. USERS ARE TRAINED TO INSPECT FOR SIGNS OF DAMAGE PRIOR TO AND DURING USE. ANY PRODUCT WITH DAMAGE IS NOT TO BE USED. INFORMATION FOR SAFETY IS PROVIDED IN THE PRODUCTS LABELING WITH THE INTENT TO MAKE THE USER AWARE OF THE RISKS. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), ALTHOUGH NOT INTENDED AS A MITIGATION OF RISK, ¿IF STRONG RESISTANCE IS MET DURING MANIPULATION, DISCONTINUE THE PROCEDURE, AND DETERMINE THE CAUSE OF THE RESISTANCE BEFORE PROCEEDING. IF THE CAUSE OF THE RESISTANCE CANNOT BE DETERMINED, WITHDRAW THE CATHETER. TORQUING THE GUIDING CATHETER EXCESSIVELY WHILE KINKED MAY CAUSE DAMAGE WHICH COULD RESULT IN POSSIBLE SEPARATION ALONG THE CATHETER SHAFT. SHOULD THE GUIDING CATHETER SHAFT BECOME SEVERELY KINKED, WITHDRAW THE ENTIRE SYSTEM (GUIDING CATHETER, GUIDEWIRE AND CATHETER SHEATH INTRODUCER)¿ BASED ON THE INFORMATION AVAILABLE AND THE PHR REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE DESIGN OR MANUFACTURING PROCESS. THEREFORE, NO PREVENTATIVE OR CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.
A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH LOT 18072620 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. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
THE PRODUCT HISTORY REVIEW IS EXPECTED BUT HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
AS REPORTED, A 6F .070 100 CM VISTA BRITE TIP XB RCA GUIDING CATHETER WAS FOUND BROKEN INTO MANY PARTS AFTER ONE HOUR OF TRYING TO ROTATE AND CORRECT THE POSITION OF THE GUIDING CATHETER. THE PROXIMAL PART WAS TAKEN OUT SUCCESSFULLY WITH AN UNKNOWN SNARE DEVICE. THE DISTAL PART HAD FLOWN DOWN TO THE ILIAC ARTERY. THE REMOVAL NEEDED VASCULAR SURGERY ASSISTANCE AND IT HAPPENED SUCCESSFULLY IN THE OPERATING ROOM (OR). PATIENT WAS TAKEN TO INTENSIVE CARE AFTER THE PROCEDURE, BUT NO FURTHER COMPLICATION HAPPENED. THE DEVICE WAS PULLED FROM THE PACKAGING BY THE HUB. THE DEVICE WAS TORQUED OR ¿STEERED¿ BY THE HUB. THE CATHETER DID NOT BECOME ENTRAPPED AT ANY POINT IN THE PROCEDURE. THE VESSEL CHARACTERISTICS AT THE TARGET SITE WERE MILD CALCIFICATION, MODERATE TORTUOSITY, AND 99% STENOSIS, NO ACUTE ANGLE OR BIFURCATING. THE VESSEL CHARACTERISTICS AT THE ACCESS SITE WERE MILD CALCIFICATION, MILD TORTUOSITY, NO STENOSIS, ACUTE ANGLE OR BIFURCATING. THE DEVICE WAS USED IN A PATIENT WHO HAD A COMPLEX CORONARY INTERVENTION INVOLVING THE RIGHT CORONARY ARTERY (RCA) WITH A CONTRALATERAL APPROACH USED. THE USER IS THE HEAD OF INTERVENTIONAL CARDIOLOGY DEPARTMENT AND HAS AN EXPERIENCE OF FIFTEEN YEARS IN INTERVENTIONAL CARDIOLOGY WITH PERFORMING MORE THAN FIVE HUNDRED PERCUTANEOUS CORONARY INTERVENTION (PCI) PER YEAR. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN, UNAVAILABLE, NOT ANSWERED, OR NOT APPLICABLE. THE DEVICE WILL BE RETURNED FOR EVALUATION.
AS REPORTED, A 6F .070 100 CM VISTA BRITE TIP XB RCA GUIDING CATHETER WAS FOUND BROKEN INTO MANY PARTS AFTER ONE HOUR OF TRYING TO ROTATE AND CORRECT THE POSITION OF THE GUIDING CATHETER. THE PROXIMAL PART WAS TAKEN OUT SUCCESSFULLY WITH AN UNKNOWN SNARE DEVICE. THE DISTAL PART HAD FLOWN DOWN TO THE ILIAC ARTERY. THE REMOVAL NEEDED VASCULAR SURGERY ASSISTANCE AND IT HAPPENED SUCCESSFULLY IN THE OPERATING ROOM (OR). PATIENT WAS TAKEN TO INTENSIVE CARE AFTER THE PROCEDURE, BUT NO FURTHER COMPLICATION HAPPENED. THE DEVICE WAS USED IN A PATIENT WHO HAD A COMPLEX CORONARY INTERVENTION INVOLVING THE RIGHT CORONARY ARTERY (RCA). THE USER IS THE HEAD OF INTERVENTIONAL CARDIOLOGY DEPARTMENT AND HAS AN EXPERIENCE OF FIFTEEN YEARS IN INTERVENTIONAL CARDIOLOGY WITH PERFORMING MORE THAN FIVE HUNDRED PERCUTANEOUS CORONARY INTERVENTION (PCI) PER YEAR. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1356941 | VISTA BRITE TIP | CATHETER, PERCUTANEOUS | DQY | CORDIS US CORP | 18072620 | 20705032020854 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Male | Life Threatening| R | UNKNOWN SNARE DEVICE. |