ULTRAFLEX IAB: 7.5FR 40CC
Report
- Report Number
- 3010532612-2022-00461
- Event Type
- Malfunction
- Date Received
- October 27, 2022
- Date of Event
- September 30, 2022
- Report Date
- October 17, 2022
- Manufacturer
- ARROW INTERNATIONAL LLC
- Product Code
- DSP
- UDI-DI
- 10801902145731
- PMA / PMN Number
- K000729
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). THE REPORTED COMPLAINT THAT THE "MACHINE FREQUENTLY ALARMED FOR HELIUM LOSS" WAS CONFIRMED BASED ON VISUAL INSPECTION OF THE RETURNED SAMPLE. THE CUSTOMER RETURNED A 40CC 7.5FR ULTRAFLEX INTRA-AORTIC BALLOON CATHETER (IABC) WITHOUT THE ORIGINAL PACKAGING FOR INVESTIGATION. THE SAMPLE WAS RETURNED IN A CARDBOARD BOX AND WAS IN A PLASTIC BAG (INP-1, INP-2). THE SAMPLE WAS LOOSELY PACKED WITHIN AN ORIGINAL PACKAGING TRAY (INP-2). RETURNED WITH THE SAMPLE WERE SUPPLIED KIT COMPONENTS INCLUDING 8FR TEFLON SHEATH, 8FR DILATOR, PRE-DILATOR, 60CC LUER-SLIP SYRINGE, SHORT/LONG ARTERIAL PRESSURE TUBING, 0.025IN GUIDEWIRE, 40CC INFLATION DRIVELINE TUBING AND DATA-SCOPE INFLATION DRIVELINE TUBING; ALL RETURNED COMPONENTS WERE VISUALLY INSPECTED, AND NO DAMAGE OR ABNORMALITIES WERE NOTED (INP-5). NO DAMAGE OR ABNORMALITIES WERE NOTED TO THE RETURNED ORIGINAL PACKAGING TRAY (INP-18). UPON RETURN, THE IABC BLADDER WAS NOTED WITHDRAWN THROUGH A NON-TELEFLEX SHEATH AND THE SHEATH WAS NOTED ON THE IABC BLADDER MEMBRANE (INP-4, INP-7). THE SHEATH HUB WAS NOTED AT APPROXIMATELY 59.5CM FROM THE IABC LUER END (INP-4, INP-7). THE SHEATH EXTRUSION WAS NOTED DAMAGED; BUCKLING WAS NOTED THROUGHOUT THE SHEATH EXTRUSION (INP-8). THE 0.025" GUIDEWIRE WAS NOTED PARTIALLY INSERTED WITHIN THE IABC CENTRAL LUMEN; MULTIPLE BENDS WERE NOTED ON THE GUIDEWIRE (INP-4). THE ONE-WAY VALVE WAS NOTED TETHERED TO THE SHORT DRIVELINE TUBING (INP-6). THE EXPOSED PORTION OF THE IABC BLADDER WAS FULLY UNWRAPPED (INP-7). A BEND TO THE IABC FLEX-TIP ASSEMBLY (PART OF THE IABC CENTRAL LUMEN) WAS NOTED AT APPROXIMATELY 1.9CM FROM THE IABC DISTAL TIP (INP-9). MULTIPLE BENDS TO THE IABC CENTRAL LUMEN WERE NOTED AT APPROXIMATELY 9.5CM, 48CM AND 72CM FROM THE IABC LUER END (INP-10, INP-11, AND INP-12). THE IABC FLEX-TIP ASSEMBLY (PART OF THE IABC CENTRAL LUMEN) WAS NOTED DAMAGED AND BROKEN AT APPROXIMATELY 6.7CM FROM THE IABC DISTAL TIP AND WIRE-ROUND WAS NOTED UNRAVELED WITHIN THE AREA OF THE DAMAGED FLEX-TIP ASSEMBLY (INP-13 THROUGH INP-17). DRIED BLOOD WAS NOTED ON THE EXTERIOR SURFACES OF THE RETURNED IABC. DRIED BLOOD WAS ALSO NOTED WITHIN THE HELIUM PATHWAY. SINCE THE IABC BLADDER WAS NOTED WITHDRAWN THROUGH A NON-TELEFLEX SHEATH AND BUCKLING WAS NOTED TO THE SHEATH EXTRUSION, AN IN-SERVICE HAS BEEN REQUESTED TO REVIEW THE INSTRUCTIONS FOR USE (IFU) WITH THE CUSTOMER. THE INSTRUCTIONS FOR USE (IFU) STATES: "DO NOT REMOVE ARROW IAB THROUGH HEMOSTASIS SHEATH INTRODUCER OR HEMOSTASIS DEVICE. ONCE UNWRAPPED (UNFURLED), BALLOON PROFILE WILL NOT ALLOW PASSAGE THROUGH THE SHEATH AND ATTEMPTED REMOVAL IN THIS MANNER MAY RESULT IN ARTERIAL TEARING, DISSECTION OR BALLOON DAMAGE." THE BLADDER THICKNESS WAS MEASURED AT SIX POINTS WITH MEASUREMENTS RANGING FROM 0.0055IN-0.0059IN AND WAS WITHIN SPECIFICATION OF PROCESS DOCUMENT. THE ONE-WAY VALVE WAS TESTED AND PASSED. A VACUUM WAS PULLED ON THE ONE-WAY VALVE, AND IT HELD FOR AT LEAST 1 MINUTE AND THEN 30 SECONDS FIVE SEPARATE TIMES IN ACCORDANCE WITH QUALITY SYSTEM DOCUMENT. THE ONE-WAY VALVE WAS CONNECTED TO THE SHORT DRIVELINE TUBING AND VACUUM WAS PULLED ON THE IABC. WHILE MAINTAINING THE VACUUM, THE SHEATH WAS MOVED FROM THE BLADDER AND TOWARDS THE BIFURCATE WITH MINIMAL FORCE REQUIRED. UPON REMOVAL OF THE SHEATH FROM THE IABC BLADDER, NO VISUAL DAMAGE OR ABNORMALITIES WERE NOTED TO THE IABC BLADDER (ANP-1). THE IABC WAS LEAK TESTED IN ACCORDANCE WITH TESTING METHODS FROM MA NUFACTURING PROCEDURE. MULTIPLE LEAKS WERE IMMEDIATELY DETECTED FROM THE BLADDER MEMBRANE (ANP-2). UNDER MICROSCOPIC INSPECTION, A TOTAL OF 3 LEAK SITES CONSISTENT WITH CONTACT FROM A SHARP OBJECT WERE NOTED; ONE (1) LEAK SITE WAS NOTED AT APPROXIMATELY 5.5CM FROM THE IABC DISTAL TIP AND A TOTAL OF TWO (2) REPEATED LEAK SITES WERE NOTED AT APPROXIMATELY 8.6CM FROM THE IABC DISTAL TIP (ANP-3 THROUGH ANP-5). UPON FURTHER MICROSCOPIC INSPECTION, THE IABC BLADDER WAS NOTED DAMAGED FROM APPROXIMATELY 10.7CM TO 11.1CM FROM THE IABC DISTAL TIP (ANP-6 AND ANP-7). THE IABC CENTRAL LUMEN WAS UNABLE TO BE ASPIRATED AND FLUSHED, AS THE 0.025" GUIDEWIRE WAS STUCK AND COULD NOT BE REMOVED FROM THE IABC. DUE TO THE DAMAGES AND RETURNED STATE OF THE DEVICE, IT COULD NOT BE CONFIDENTLY DETERMINED WHEN THE DAMAGES OCCURRED (I.E., DURING THERAPY, DURING DEVICE REMOVAL OR AFTER THE DEVICE WAS REMOVED). BASED ON A REVIEW OF THE DEVICE HISTORY RECORD (DHR), THE PRODUCT MET SPECIFICATION UPON RELEASE; HOWEVER, THE SPECIFICATIONS WERE NOT MET DURING THE COMPLAINT INVESTIGATION DUE TO THE DAMAGED CATHETER. THE ROOT CAUSE OF THE COMPLAINT WAS UNDETERMINED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE. OTHER REMARKS: N/A. CORRECTED DATA: N/A.
QN# (B)(4).
(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE, THE COMPLAINT COULD NOT BE CONFIRMED, AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE. OTHER REMARKS: N/A. CORRECTED DATA: N/A.
THE REPORT STATES "AFTER 3 MINUTES OF USE, THE MACHINE FREQUENTLY ALARMED FOR HELIUM LOSS. THE ISSUE COULD NOT BE RESOLVED BY ADJUSTING THE EQUIPMENT AND THE CATHETER. AS A RESULT, THE CATHETER WAS REPLACED, AND THE PROBLEM WAS SOLVED. THE SECOND CATHETER WAS INSERTED AT THE SAME INSERTION SITE". THE CURRENT PATIENT CONDITION IS REPORTED AS "FINE".
THE REPORT STATES "AFTER 3 MINUTES OF USE, THE MACHINE FREQUENTLY ALARMED FOR HELIUM LOSS. THE ISSUE COULD NOT BE RESOLVED BY ADJUSTING THE EQUIPMENT AND THE CATHETER. AS A RESULT, THE CATHETER WAS REPLACED, AND THE PROBLEM WAS SOLVED. THE SECOND CATHETER WAS INSERTED AT THE SAME INSERTION SITE". THE CURRENT PATIENT CONDITION IS REPORTED AS "FINE".
THE REPORT STATES "AFTER 3 MINUTES OF USE, THE MACHINE FREQUENTLY ALARMED FOR HELIUM LOSS. THE ISSUE COULD NOT BE RESOLVED BY ADJUSTING THE EQUIPMENT AND THE CATHETER. AS A RESULT, THE CATHETER WAS REPLACED, AND THE PROBLEM WAS SOLVED. THE SECOND CATHETER WAS INSERTED AT THE SAME INSERTION SITE". THE CURRENT PATIENT CONDITION IS REPORTED AS "FINE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2721001 | ULTRAFLEX IAB: 7.5FR 40CC | SYSTEM, BALLOON, INTRA-AORTIC | DSP | ARROW INTERNATIONAL LLC | IPN039788 | 18F22D0048 | 10801902145731 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Male |