CATH F5.2+ PIG 145° 110CM 6SH
Report
- Report Number
- 9616099-2024-00252
- Event Type
- Death
- Date Received
- August 1, 2024
- Date of Event
- June 11, 2024
- Report Date
- October 19, 2024
- Manufacturer
- CORDIS US CORP
- Product Code
- DQO
- PMA / PMN Number
- K914007
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
SECTION B5 (DESCRIBE EVENT OR PROBLEM) WAS UPDATED. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
AS INITIALLY REPORTED BY THE FACILITY TO BFARM, DUE TO A DEFECT IN A 5.2 F SUPER TORQUE PLUS ANGLED 6 SIDE HOLES PIGTAIL CATHETER (LEAKAGE FROM THE CATHETER), AIR LEAKED INTO THE CIRCULATION, LEADING TO AN AIR EMBOLISM. THE AIR EMBOLISM CAUSED BRAIN DAMAGE WITH SUBSEQUENT CEREBRAL EDEMA, AND ULTIMATELY, THE PATIENT DIED NINE DAYS LATER. HOWEVER, DURING FURTHER INVESTIGATION, THERE IS NO EVIDENCE THE AIR EMBOLISM IS RELATED TO THE DEVICE. THE INCIDENT OCCURRED DURING A LEFT ATRIAL APPENDAGE (LAA) OCCLUDER PROCEDURE, FOR WHICH A CONTRALATERAL APPROACH WAS NOT USED. THE PHYSICIAN INDICATED THAT THEY COULD NOT SEE AIR BUBBLES IN THE CATHETER INITIALLY BUT SAW THE AIR BUBBLES IN THE HEART POST PROCEDURE. THERE WAS A LEAK AT THE CONNECTION OF THE HUB-SHAFT (ABOUT A 1 CM HORIZONTAL CRACK), AND WHILE ASPIRATING AT THE THREE-WAY STOPCOCK, AIR WAS SEEN IN THE HEART AFTER THE NON-CORDIS SHEATH, DESIGNED FOR THE LAA OCCLUDER DEVICE, WAS BROUGHT IN AND PRIOR TO THE IMPLANT OF THE OCCLUDER DEVICE, BUT THE PROCEDURE CONTINUED WITH THE IMPLANT. THE PHYSICIAN DIRECTLY OBSERVED THE CRACK AND STATED IT MAY BE THE ROOT CAUSE OF THE PATIENT OUTCOME, BUT THEY ARE NOT SURE. ON A SUBSEQUENT FOLLOW UP, THE PHYSICIAN CLARIFIED THAT THE CRACK IN THE CATHETER COULD BE THE REASON WHY AIR GOT INTO THE SYSTEM BUT WAS LIKELY NOT THE CAUSE OF THE PATIENT¿S DEATH. THE PHYSICIAN FURTHER CLARIFIED THAT AIR WAS NOT SEEN ON ASPIRATION BUT WAS VISIBLE IN THE HEART LATER DUE TO THE NEGATIVE PRESSURE PRODUCED BY THIS TYPE OF PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED STATING PRIOR TO THE OCCURRENCE OF THE AIR EMBOLISM, THERE WAS NO INJECTION, ONLY ASPIRATION. THE CATHETER WAS ASPIRATED AND INSPECTED FOR THE PRESENCE OF AIR PRIOR TO INJECTING THE SOLUTION INTO THE PATIENT. INITIALLY, THE EMBOLISM WAS SEEN IN THE CORONARY ARTERY AND WAS CORRECTED WITH FLUSHING. THEN AIR IN THE LEFT VENTRICLE WAS ALSO SEEN, WHICH PROBABLY CAUSED THE CEREBRAL EMBOLISM. NO OTHER DAMAGES WERE NOTED BESIDES THE CRACK. THERE WAS NO VISIBLE AIR BUBBLE IN THE SYRINGE/SYSTEM AT ANY POINT. THE CONCOMITANT DEVICES INCLUDED A NON-CORDIS J-TIP SUPER STIFF WIRE AND A NON-CORDIS SHEATH. THE AFFECTED PIGTAIL CATHETER WAS PART OF A SINGLE PACK; HOWEVER, THE REMAINING FOUR DEVICES MUST HAVE BEEN USED WITH NO ISSUES. DEVICES ARE STORED IN CLOSED CABINETS WITH NO EXPOSURE TO LIGHT, AND NO ULTRAVIOLET (UV) OR OTHER LIGHTING FOR STERILIZATION IS USED AND THE CATHETERS ARE NOT EXPOSED TO LIGHTING THROUGH CABINETS WITH GLASS DOORS. THE PATIENT HAD PREEXISTING MEDICAL CONDITIONS, INCLUDING A HISTORY OF HEMORRHAGIC STROKE. THE DEVICE WAS STORED, HANDLED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS NOT PULLED FROM THE PACKAGING BY THE HUB NOR TORQUED OR ¿STEERED¿ BY THE HUB. THERE WERE NO DIFFICULTIES ENCOUNTERED WHILE ATTEMPTING TO INSERT, ADVANCE, OR WITHDRAW THE DEVICE. THE CATHETER WAS PROPERLY FLUSHED WITH SALINE OR ANOTHER SUITABLE SOLUTION. THE TARGET SITE DID NOT HAVE CALCIFICATION, TORTUOSITY, OR STENOSIS. THE POWER INJECTOR WAS NOT BEING USED AT THE TIME THE AIR EMBOLISM OCCURRED. THE STAFF INVOLVED IN THE AIR EMBOLISM WERE VERY EXPERIENCED. THE SIZE OF THE AIR EMBOLISM WAS NOT PROVIDED BUT WAS DESCRIBED AS ¿MUCH.¿THE DEVICE WAS DISCARDED AT THE HOSPITAL AND IMAGES/PROCEDURAL FILMS ARE NOT AVAILABLE. ADDITIONALLY, A PRODUCT HISTORY RECORD (PHR) REVIEW COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER FOR THIS PRODUCT IS UNKNOWN.WITHOUT THE RETURN OF THE DEVICE OR IMAGES FOR ANALYSIS, THE REPORTED CUSTOMER EVENTS ¿CATHETER (BODY/SHAFT)-LEAKAGE AND STRAIN RELIEF-CRACKED¿ COULD NOT BE CONFIRMED. ADDITIONALLY, IT CANNOT BE DETERMINED IF THE ADVERSE EVENT ¿DEATH¿ IS RELATED TO THE SUPER TORQUE PLUS PIGTAIL CATHETER. AIR EMBOLISMS ARE A KNOWN POTENTIAL COMPLICATION, WHICH MAY OCCUR DURING ANY ANGIOGRAPHIC PROCEDURE AND IS DOCUMENTED IN THE IFU AS SUCH. IT WAS REPORTED THAT NO OTHER DAMAGES WERE NOTED BESIDES THE CRACKED STRAIN RELIEF AND THERE WAS NO VISIBLE AIR BUBBLE IN THE SYRINGE/SYSTEM AT ANY POINT. A CRACKED STRAIN RELIEF WOULD NOT RESULT IN A LEAK AS THIS COMPONENT IS A TUBE THAT IS POSITIONED OVER THE BODY OF THE CATHETER TO MINIMIZE BUCKLING AND KINKING AT THE HUB DURING USE. THIS COULD EXPLAIN WHY AIR WAS NOT SEEN IN THE SYRINGE/SYSTEM AT ANY POINT. THEREFORE, IT'S POSSIBLE THAT PROCEDURALLY RELATED FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. 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, ¿STORE IN A COOL, DARK, DRY PLACE. DO NOT USE IF PACKAGE IS OPEN OR DAMAGED. DO NOT USE THE CATHETER IF THE ¿USE BY¿ DATE ON THE PACKAGE LABEL HAS EXPIRED. DO NOT RESTERILIZE. EXPOSURE TO TEMPERATURES ABOVE 54° C (130° F) MAY DAMAGE THE CATHETER. KEEP THE CATHETER FILLED WITH EITHER FLUSHING SOLUTION OR CONTRAST MEDIUM WHILE THE CATHETER IS IN THE VASCULAR SYSTEM AND CONSIDER THE USE OF SYSTEMIC HEPARINIZATION. FORCIBLY ASPIRATE AND FLUSH THE CATHETER WITH HEPARINIZED SALINE SOLUTION AT LEAST ONCE EVERY TWO MINUTES. COMPLICATIONS MAY OCCUR AT ANY TIME DURING OR AFTER THE PROCEDURE. POSSIBLE COMPLICATIONS INCLUDE BUT ARE NOT LIMITED TO THE FOLLOWING: AIR EMBOLISM, HEMATOMA AT THE PUNCTURE SITE, INFECTION, PERFORATION OF THE VESSEL WALL.¿ AN INVESTIGATION TO FURTHER REVIEW THIS EVENT HAS BEEN INITIATED. HOWEVER, BASED ON THE VERY LIMITED INFORMATION MADE AVAILABLE FOR REVIEW AND WITHOUT RETURN OF THE PRODUCT, THERE IS NO INDICATION THAT THE AIR EMBOLISM IS RELATED TO THE DEVICE.
AS REPORTED BY THE FACILITY TO BFARM, DUE TO A DEFECT IN A 5.2 F SUPER TORQUE PLUS ANGLED 6 SIDE HOLES PIGTAIL CATHETER (LEAKAGE FROM THE CATHETER), AIR LEAKED INTO THE CIRCULATION, LEADING TO AN AIR EMBOLISM. THE AIR EMBOLISM CAUSED BRAIN DAMAGE WITH SUBSEQUENT CEREBRAL EDEMA, AND ULTIMATELY, THE PATIENT DIED NINE DAYS LATER. THE INCIDENT OCCURRED DURING A LEFT ATRIAL APPENDAGE (LAA) OCCLUDER PROCEDURE, FOR WHICH A CONTRALATERAL APPROACH WAS NOT USED. THE PHYSICIAN INDICATED THAT THEY COULD NOT SEE AIR BUBBLES IN THE CATHETER INITIALLY BUT SAW THE AIR BUBBLES IN THE HEART POST PROCEDURE. THERE WAS A LEAK AT THE CONNECTION OF THE HUB-SHAFT (ABOUT A 1 CM HORIZONTAL CRACK), AND WHILE ASPIRATING AT THE THREE-WAY STOPCOCK, AIR WAS SEEN IN THE HEART AFTER THE NON-CORDIS SHEATH, DESIGNED FOR THE LAA OCCLUDER DEVICE, WAS BROUGHT IN AND PRIOR TO THE IMPLANT OF THE OCCLUDER DEVICE, BUT THE PROCEDURE CONTINUED WITH THE IMPLANT. THE PHYSICIAN DIRECTLY OBSERVED THE CRACK AND STATED IT MAY BE THE ROOT CAUSE OF THE PATIENT OUTCOME, BUT THEY ARE NOT SURE. ON A SUBSEQUENT FOLLOW UP, THE PHYSICIAN CLARIFIED THAT THE CRACK IN THE CATHETER COULD BE THE REASON WHY AIR GOT INTO THE SYSTEM BUT WAS LIKELY NOT THE CAUSE OF THE PATIENT¿S DEATH. THE PHYSICIAN FURTHER CLARIFIED THAT AIR WAS NOT SEEN ON ASPIRATION BUT WAS VISIBLE IN THE HEART LATER DUE TO THE NEGATIVE PRESSURE PRODUCED BY THIS TYPE OF PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED STATING PRIOR TO THE OCCURRENCE OF THE AIR EMBOLISM, THERE WAS NO INJECTION, ONLY ASPIRATION. THE CATHETER WAS ASPIRATED AND INSPECTED FOR THE PRESENCE OF AIR PRIOR TO INJECTING THE SOLUTION INTO THE PATIENT. INITIALLY, THE EMBOLISM WAS SEEN IN THE CORONARY ARTERY AND WAS CORRECTED WITH FLUSHING. THEN AIR IN THE LEFT VENTRICLE WAS ALSO SEEN, WHICH PROBABLY CAUSED THE CEREBRAL EMBOLISM. NO OTHER DAMAGES WERE NOTED BESIDES THE CRACK. THERE WAS NO VISIBLE AIR BUBBLE IN THE SYRINGE/SYSTEM AT ANY POINT. THE CONCOMITANT DEVICES INCLUDED A NON-CORDIS J-TIP SUPER STIFF WIRE AND A NON-CORDIS SHEATH. THE AFFECTED PIGTAIL CATHETER WAS PART OF A SINGLE PACK; HOWEVER, THE REMAINING FOUR DEVICES MUST HAVE BEEN USED WITH NO ISSUES. DEVICES ARE STORED IN CLOSED CABINETS WITH NO EXPOSURE TO LIGHT, AND NO ULTRAVIOLET (UV) OR OTHER LIGHTING FOR STERILIZATION IS USED AND THE CATHETERS ARE NOT EXPOSED TO LIGHTING THROUGH CABINETS WITH GLASS DOORS. THE PATIENT HAD PREEXISTING MEDICAL CONDITIONS, INCLUDING A HISTORY OF HEMORRHAGIC STROKE. THE DEVICE WAS STORED, HANDLED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS NOT PULLED FROM THE PACKAGING BY THE HUB NOR TORQUED OR ¿STEERED¿ BY THE HUB. THERE WERE NO DIFFICULTIES ENCOUNTERED WHILE ATTEMPTING TO INSERT, ADVANCE, OR WITHDRAW THE DEVICE. THE CATHETER WAS PROPERLY FLUSHED WITH SALINE OR ANOTHER SUITABLE SOLUTION. THE TARGET SITE DID NOT HAVE CALCIFICATION, TORTUOSITY, OR STENOSIS. THE POWER INJECTOR WAS NOT BEING USED AT THE TIME THE AIR EMBOLISM OCCURRED. THE STAFF INVOLVED IN THE AIR EMBOLISM WERE VERY EXPERIENCED. THE SIZE OF THE AIR EMBOLISM WAS NOT PROVIDED BUT WAS DESCRIBED AS ¿MUCH.¿ THE DEVICE LOT NUMBER WAS REQUESTED; HOWEVER, IT IS NOT AVAILABLE. PROCEDURAL FILMS ARE NOT AVAILABLE. THE DEVICE WAS DISCARDED.
THE REPRESENTATIVE FROM THE COMPANY THAT MANUFACTURES THE LEFT ATRIAL OCCLUDER DEVICE REPORTED THAT DUE TO A DEFECT IN A 5.2 F SUPER TORQUE PLUS ANGLED 6 SIDE HOLES PIGTAIL CATHETER (LEAKAGE FROM THE CATHETER), AIR LEAKED INTO THE CIRCULATION, LEADING TO AN AIR EMBOLISM. THE AIR EMBOLISM CAUSED BRAIN DAMAGE WITH SUBSEQUENT CEREBRAL EDEMA, AND ULTIMATELY, THE PATIENT DIED NINE DAYS LATER. THE INCIDENT OCCURRED DURING A LEFT ATRIAL APPENDAGE (LAA) OCCLUDER PROCEDURE, FOR WHICH A CONTRALATERAL APPROACH WAS NOT USED. ADDITIONAL INFORMATION OBTAINED FROM THE PHYSICIAN INDICATED THAT THEY COULD NOT SEE AIR BUBBLES IN THE CATHETER INITIALLY, BUT THEY SAW THE AIR BUBBLES LATER IN THE HEART. THERE WAS A LEAKAGE AT THE CONNECTION OF THE HUB-SHAFT (ABOUT A 1 CM CRACK), AND WHILE ASPIRATING AT THE THREE-WAY STOPCOCK, AIR WAS SEEN. THE CRACK WAS LOCATED AT THE TRANSITION FROM THE SHAFT TO THE HUB. THE CRACK WAS OBSERVED BY THE PHYSICIAN AND NOT BY THE REPRESENTATIVE FROM THE COMPANY THAT MANUFACTURES THE OCCLUDER DEVICE. THE PHYSICIAN STATED THE CRACK MAY BE THE ROOT CAUSE, BUT THEY ARE NOT SURE. ON A SUBSEQUENT FOLLOW UP, THE PHYSICIAN STATED THAT THE CRACK IN THE CATHETER COULD BE THE REASON WHY AIR GOT INTO THE SYSTEM, BUT IT SHOULD NOT BE THE CAUSE OF THE PATIENT¿S DEATH. AIR WAS SEEN IN THE HEART AFTER THE NON-CORDIS SHEATH, DESIGNED FOR THE LAA, WAS BROUGHT IN AND PRIOR TO THE IMPLANT OF THE LAA, BUT THE PROCEDURE CONTINUED WITH THE IMPLANT. THE LOT OF THE COMPLAINT DEVICE WAS NOT PROVIDED. THE CONCOMITANT DEVICES INCLUDED A NON-CORDIS J-TIP SUPER STIFF WIRE AND A NON-CORDIS SHEATH. THE AFFECTED PIGTAIL CATHETER WAS PART OF A SINGLE PACK (5 IN A BOX). THE REMAINING FOUR DEVICES MUST HAVE BEEN USED WITH NO ISSUES. DEVICES ARE STORED IN CLOSED CABINETS WITH NO EXPOSURE TO LIGHT, AND NO ULTRAVIOLET (UV) OR OTHER LIGHTING FOR STERILIZATION IS USED. THE CATHETERS ARE NOT EXPOSED TO LIGHTING THROUGH CABINETS WITH GLASS DOORS. NO OTHER DAMAGES WERE NOTED BESIDES THE CRACK, WHICH WAS AT THE ATTACHMENT ON THE BLUE STRAIN RELIEF. THE PATIENT HAD PREEXISTING MEDICAL CONDITIONS, INCLUDING A HISTORY OF HEMORRHAGIC STROKE. THE PHYSICIAN EXPLAINED THAT AIR WAS NOT SEEN ON ASPIRATION BUT WAS VISIBLE IN THE HEART LATER DUE TO THE NEGATIVE PRESSURE PRODUCED BY THIS TYPE OF PROCEDURE. THE CRACK WAS REPORTEDLY RIGHT NEAR THE HUB ON THE SHAFT AND WAS A HORIZONTAL CRACK. THE TARGET SITE DID NOT HAVE CALCIFICATION, TORTUOSITY, OR STENOSIS. THE DEVICE LOT NUMBER WAS REQUESTED; HOWEVER, IT WAS NOT PROVIDED. THE DEVICE WAS STORED, HANDLED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS NOT PULLED FROM THE PACKAGING BY THE HUB NOR TORQUED OR ¿STEERED¿ BY THE HUB. THERE WERE NO DIFFICULTIES ENCOUNTERED WHILE ATTEMPTING TO INSERT, ADVANCE, OR WITHDRAW THE DEVICE. THE CATHETER WAS PROPERLY FLUSHED WITH SALINE OR ANOTHER SUITABLE SOLUTION. THE POWER INJECTOR WAS NOT BEING USED AT THE TIME THE AIR EMBOLISM OCCURRED. ADDITIONAL INFORMATION WAS REQUESTED TO DETERMINE WHY THE USE OF THE DEVICE WAS CONTINUED AFTER AIR WAS SEEN WHILE ASPIRATING AT THE THREE-WAY STOPCOCK. THE RESPONSE INDICATED THAT PRIOR TO THE OCCURRENCE OF THE AIR EMBOLISM, THERE WAS NO INJECTION, ONLY ASPIRATION. THE CATHETER WAS ASPIRATED AND INSPECTED FOR THE PRESENCE OF AIR PRIOR TO INJECTING THE SOLUTION INTO THE PATIENT. THERE WAS NO VISIBLE AIR BUBBLE IN THE SYRINGE/SYSTEM AT ANY POINT. THE STAFF INVOLVED IN THE AIR EMBOLISM WERE VERY EXPERIENCED. THE SIZE OF THE AIR EMBOLISM WAS NOT PROVIDED BUT WAS DESCRIBED AS ¿MUCH.¿ INITIALLY, THE EMBOLISM WAS SEEN IN THE CORONARY ARTERY AND WAS CORRECTED WITH FLUSHING. THEN AIR IN THE LEFT VENTRICLE WAS ALSO SEEN, WHICH PROBABLY CAUSED THE CEREBRAL EMBOLISM. PROCEDURAL FILMS ARE NOT CURRENTLY AVAILABLE. THE ACCOUNT DOES NOT HAVE A SYSTEM FOR TRACKING OF DEVICES THAT ARE USED IN THE CASE VIA SCANNING THE PRODUCT PACKAGING AND ATTACHING THE LABELS TO THE CHART. THE DEVICE WAS DISCARDED.
AS REPORTED, DUE TO A DEFECT IN THE UNKNOWN ANGIOGRAPHY PIGTAIL CATHETER (LEAKAGE FROM THE CATHETER), AIR LEAKED INTO THE CIRCULATION, LEADING TO AN AIR EMBOLISM. THE AIR EMBOLISM LED TO BRAIN DAMAGE WITH SUBSEQUENT CEREBRAL EDEMA. ULTIMATELY, THE PATIENT DIED NINE DAYS LATER. THE INCIDENT OCCURRED DURING A LEFT ATRIAL APPENDAGE (LAA) OCCLUDER PROCEDURE. WHILE HAVING THIS PROBLEM WITH AIR-EMBOLI, THEY REALIZED THAT THE DIAGNOSTIC CATHETER HAD A LEAKAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1217463 | CATH F5.2+ PIG 145° 110CM 6SH | CATHETER, INTRAVASCULAR, DIAGNOSTIC | DQO | CORDIS US CORP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Death | UNKNOWN. |