ANGIOGUARD RX
Report
- Report Number
- 1016427-2024-00020
- Event Type
- Injury
- Date Received
- July 16, 2024
- Date of Event
- June 22, 2024
- Report Date
- August 28, 2024
- Manufacturer
- CORDIS US CORP.
- Product Code
- NTE
- UDI-DI
- 10705032056717
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
CORRECTED DATA: CHANGED FORMER MEDICAL DEVICE PROBLEM CODE OF "1528 DIFFICULT TO REMOVE" TO "1536 RETRACTION PROBLEM"; UPDATED PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
THE DEVICE WAS RECEIVED FOR ANALYSIS, BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS HAVE BEEN UPDATED ACCORDINGLY: G3, G6, H2, H3, H6, AND H10. COMPLAINT CONCLUSION: AS REPORTED, THE UMBRELLA OF A 6MM (BASKET DIAMETER)/180CM ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE COULD NOT BE RETRIEVED. THE 4 NITINOL POINTS COULD NOT BE COMBINED INTO ONE, AND THE UMBRELLA COULD NOT ENTER THE CAPTURE SHEATH AFTER THE PROCEDURE WAS COMPLETED. THE OPERATOR USED A STANDARD METHOD OF UMBRELLA FLUSHING WHEN PERFORMING PERCUTANEOUS PUNCTURE, CAROTID BALLOON DILATATION, AND STENTING ON THE PATIENT. AFTER LOADING, THE UMBRELLA WAS INSERTED INTO THE PATIENT'S BODY AND THE PROCEDURE WAS PERFORMED. WHEN THE UMBRELLA WAS RETRIEVED, IT COULD NOT BE WITHDRAWN AS THE 4 NITINOL POINTS COULD NOT BE COMBINED INTO ONE, PREVENTING THE UMBRELLA FROM ENTERING THE CAPTURE SHEATH. IT WAS THEN RETRIEVED USING A 125CM SINGLE-CURVE UNKNOWN CATHETER AND WAS WITHDRAWN FROM THE BODY WITHOUT INCIDENT. THERE WERE NO REPORTS OF PATIENT INJURY. THE TARGET VESSEL FOR THE PROCEDURE WAS THE RIGHT INTERNAL CAROTID ARTERY. AT THE TARGET SITE, THE VESSEL HAD NO CALCIFICATION, MILD TORTUOSITY, AND AN 80% STENOSIS RATE. THERE WAS NO ACUTE ANGLE OR BIFURCATION, AND NO CHRONIC TOTAL OCCLUSION WAS PRESENT. A MILD THROMBUS WAS OBSERVED BEFORE, AT, OR AFTER THE LESION SITE. THE LESION WAS PRE-DILATED BEFORE STENT IMPLANTATION USING A NON-CORDIS BALLOON AT 14 ATMOSPHERES, REDUCING STENOSIS TO 50%. THE PROCEDURE WAS COMPLETED BY RETRIEVING THE FILTER WITH AN UNKNOWN 5F SINGLE-BEND DEVICE. THERE WAS NO DIFFICULTY ADVANCING THE CAPTURE SHEATH TO THE LESION, AND DURING FILTER RETRIEVAL, THE RETRIEVAL SHEATH WAS ADVANCED WHILE THE FILTER WIRE WAS FIXED. THE FILTER BASKET WAS SLIGHTLY DEFORMED, BUT NO EXCESS FORCE WAS REQUIRED FOR WITHDRAWAL. THE FILTER WAS POSITIONED DISTALLY ENOUGH TO PREVENT INTERACTION WITH THE BALLOONS OR STENT DELIVERY SYSTEM (SDS) USED, AND THERE WAS NO INTERACTION BETWEEN THE FILTER BASKET'S PROXIMAL MARKER BAND AND THE DISTAL END OF OTHER DEVICES. THE CAPTURE SHEATH WAS ADVANCED UNTIL THE MARKER BAND LINED UP WITH THE PROXIMAL FILTER BASKET MARKER BAND. ALTHOUGH THE FILTER BASKET'S DIAMETER WAS REDUCED, THE FOUR MARKERS DID NOT MERGE INTO A SINGLE MARKER, AND THE OPERATOR, CONCERNED ABOUT THE RECOVERY INDICATOR, DID NOT FORCE RETRIEVAL TO AVOID FILTER INTERFERENCE WITH THE STENT. A SECOND ANGIOGUARD DEVICE WAS NOT OPENED FOR RETRIEVAL. THE PATIENT HAS BEEN DISCHARGED WITH NO INJURY REPORTED. A NON-STERILE ¿RX/6MM BASKET DIAMETER/180CM¿ WAS RECEIVED INSIDE OF A CLEAR PLASTIC BAG. THE DEVICE WAS UNPACKED TO PERFORM THE VISUAL EVALUATION. THE RETURNED COMPONENTS ARE THE DEPLOYMENT SHEATH, THE CAPTURE SHEATH, THE ECGW SYSTEM, THE TORQUING DEVICE AND THE PEEL AWAY INTRODUCER. THE REST OF THE COMPONENTS WERE NOT RETURNED FOR ANALYSIS. THE ECGW SYSTEM WAS NOT INSERTED INSIDE THE CAPTURE SHEATH OR THE DELIVERY SHEATH. NO OTHER OUTSTANDING DETAILS WERE OBSERVED ON THE RETURNED PART. FOR FUNCTIONAL ANALYSIS, THE GUIDEWIRE OF THE ECGW SYSTEM WAS RECAPTURED BY INSERTING IT INTO THE CAPTURE SHEATH BY THE DISTAL TIP UNTIL THE PROXIMAL END WAS SEEN OUT OF THE RAPID EXCHANGE PORT. THE ECGW SYSTEM GUIDEWIRE WAS ADVANCED OVER THE WIRE UNTIL THE SHEATH MARKER MET THE PROXIMAL BASKET MARKER CAPTURING THE FILTER BASKET. NO ANOMALIES WERE OBSERVED. THE FILTER BASKET WAS MAGNIFIED WITH A VISION SYSTEM TO PERFORM THE EVALUATION. AS A RESULT OF THIS INSPECTION NO ANOMALIES OR DAMAGES WERE OBSERVED ON THE FILTER STRUTS OR THE MEMBRANE WALLS. THE FAILURE REPORTED BY THE CUSTOMER AS ¿CAPTURE SYSTEM~ CAPTURE DIFFICULTY¿ WAS NOT CONFIRMED, THE FILTER BASKET WAS RECAPTURED INTO THE CAPTURE SHEATH WITH NO ANOMALIES OBSERVED. THE FAILURE REPORTED BY THE CUSTOMER AS ¿FILTER BASKET~DAMAGED¿ WAS NOT CONFIRMED, THE FILTER BASKET DID NOT PRESENT WITH ANY DAMAGES OR ANOMALIES. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED DURING THE ANALYSIS. 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, ¿PRIOR TO THE INTERVENTIONAL PROCEDURE, ALL EQUIPMENT AND PACKAGING, INCLUDING THE ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM, SHOULD BE INSPECTED AND EXAMINED CAREFULLY FOR DEFECTS. CHECK GUIDEWIRE, FILTER BASKET, DEPLOYMENT SHEATH, CAPTURE SHEATH, AND CAPTURE SHEATH RX PORT REGION (APPROXIMATELY 30 CM FROM THE DISTAL TIP) FOR BENDS, KINKS, OR OTHER DAMAGE. DO NOT USE DEFECTIVE EQUIPMENT.¿ BASED ON THE AVAILABLE INFORMATION, 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.
AS REPORTED, THE UMBRELLA OF A 6MM (BASKET DIAMETER)/180CM ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE COULD NOT BE RETRIEVED. THE 4 NITINOL POINTS COULD NOT BE COMBINED INTO ONE, AND THE UMBRELLA COULD NOT ENTER THE CAPTURE SHEATH AFTER THE PROCEDURE WAS COMPLETED. THE OPERATOR USED A STANDARD METHOD OF UMBRELLA FLUSHING WHEN PERFORMING PERCUTANEOUS PUNCTURE, CAROTID BALLOON DILATATION, AND STENTING ON THE PATIENT. AFTER LOADING, THE UMBRELLA WAS INSERTED INTO THE PATIENT'S BODY AND THE PROCEDURE WAS PERFORMED. WHEN THE UMBRELLA WAS RETRIEVED, IT COULD NOT BE WITHDRAWN AS THE 4 NITINOL POINTS COULD NOT BE COMBINED INTO ONE, PREVENTING THE UMBRELLA FROM ENTERING THE CAPTURE SHEATH. IT WAS THEN RETRIEVED USING A 125CM SINGLE-CURVE UNKNOWN CATHETER AND WAS WITHDRAWN FROM THE BODY WITHOUT INCIDENT. THERE WERE NO REPORTS OF PATIENT INJURY. THE TARGET VESSEL FOR THE PROCEDURE WAS THE RIGHT INTERNAL CAROTID ARTERY. AT THE TARGET SITE, THE VESSEL HAD NO CALCIFICATION, MILD TORTUOSITY, AND AN 80% STENOSIS RATE. THERE WAS NO ACUTE ANGLE OR BIFURCATION, AND NO CHRONIC TOTAL OCCLUSION WAS PRESENT. A MILD THROMBUS WAS OBSERVED BEFORE, AT, OR AFTER THE LESION SITE. THE LESION WAS PRE-DILATED BEFORE STENT IMPLANTATION USING A NON-CORDIS BALLOON AT 14 ATMOSPHERES, REDUCING STENOSIS TO 50%. THE PROCEDURE WAS COMPLETED BY RETRIEVING THE FILTER WITH AN UNKNOWN 5F SINGLE-BEND DEVICE. THERE WAS NO DIFFICULTY ADVANCING THE CAPTURE SHEATH TO THE LESION, AND DURING FILTER RETRIEVAL, THE RETRIEVAL SHEATH WAS ADVANCED WHILE THE FILTER WIRE WAS FIXED. THE FILTER BASKET WAS SLIGHTLY DEFORMED, BUT NO EXCESS FORCE WAS REQUIRED FOR WITHDRAWAL. THE FILTER WAS POSITIONED DISTALLY ENOUGH TO PREVENT INTERACTION WITH THE BALLOONS OR STENT DELIVERY SYSTEM (SDS) USED, AND THERE WAS NO INTERACTION BETWEEN THE FILTER BASKET'S PROXIMAL MARKER BAND AND THE DISTAL END OF OTHER DEVICES. THE CAPTURE SHEATH WAS ADVANCED UNTIL THE MARKER BAND LINED UP WITH THE PROXIMAL FILTER BASKET MARKER BAND. ALTHOUGH THE FILTER BASKET'S DIAMETER WAS REDUCED, THE FOUR MARKERS DID NOT MERGE INTO A SINGLE MARKER, AND THE OPERATOR, CONCERNED ABOUT THE RECOVERY INDICATOR, DID NOT FORCE RETRIEVAL TO AVOID FILTER INTERFERENCE WITH THE STENT. A SECOND ANGIOGUARD DEVICE WAS NOT OPENED FOR RETRIEVAL. THE PATIENT HAS BEEN DISCHARGED WITH NO INJURY REPORTED. THE DEVICE WILL BE RETURNED FOR EVALUATION.
AS REPORTED, THE UMBRELLA OF A 6MM (BASKET DIAMETER)/180CM ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE COULD NOT BE RETRIEVED. THE 4 NITINOL POINTS COULD NOT BE COMBINED INTO ONE, AND THE UMBRELLA COULD NOT ENTER THE CAPTURE SHEATH AFTER THE PROCEDURE WAS COMPLETED. THE OPERATOR USED A STANDARD METHOD OF UMBRELLA FLUSHING WHEN PERFORMING PERCUTANEOUS PUNCTURE, CAROTID BALLOON DILATATION, AND STENTING ON THE PATIENT. AFTER LOADING, THE UMBRELLA WAS INSERTED INTO THE PATIENT'S BODY AND THE PROCEDURE WAS PERFORMED. WHEN THE UMBRELLA WAS RETRIEVED, IT COULD NOT BE WITHDRAWN AS THE 4 NITINOL POINTS COULD NOT BE COMBINED INTO ONE, PREVENTING THE UMBRELLA FROM ENTERING THE CAPTURE SHEATH. IT WAS THEN RETRIEVED USING A 125CM SINGLE-CURVE UNKNOWN CATHETER AND WAS WITHDRAWN FROM THE BODY WITHOUT INCIDENT. THERE WERE NO REPORTS OF PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2518642 | ANGIOGUARD RX | TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE | NTE | 35270434 | 10705032056717 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | CORDIS 5F PIGTAIL, SINGLE BAY CATHETER.| USE TERUMO 8F VASCULAR SHEATH. |