ULTRAFLEX IAB: 7.5FR 30CC
Report
- Report Number
- 3010532612-2023-00493
- Event Type
- Malfunction
- Date Received
- September 1, 2023
- Date of Event
- June 29, 2023
- Report Date
- August 17, 2023
- Manufacturer
- ARROW INTERNATIONAL LLC
- Product Code
- DSP
- UDI-DI
- 00801902003751
- PMA / PMN Number
- K000729
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4).
(B)(4). NO SERIAL NUMBER WAS REPORTED. THE SERIAL NUMBER ON THE RETURNED SAMPLE IS BK30023. THE LOT NUMBER (18F23B0006) RECORDED ON THE COMPLAINT REPORT MATCHES THE LOT NUMBER FOR THE RETURNED SAMPLE. RETURNED FOR INVESTIGATION WAS A 30CC 7.5FR ULTRAFLEX INTRA-AORTIC BALLOON CATHETER (IABC) WITH THE ORIGINAL PACKAGING BOX THAT DOES NOT MATCH THE SERIAL NUMBER ON THE RETURNED SAMPLE. RETURNED WITH THE SAMPLE WERE KIT COMPONENTS INCLUDING 60CC LUER-SLIP SYRINGE, SHORT ARTERIAL PRESSURE TUBING , PRE-DILATOR, 8FR TEFLON SHEATH W/DILATOR AND 8FR TEFLON SHEATH W/DILATOR AND SIDEARM ASSEMBLY; NO DAMAGE OR ABNORMALITIES WERE NOTED. UPON RETURN, THE ONE-WAY VALVE WAS TETHERED TO THE SHORT DRIVELINE TUBING. THE BLADDER WAS FULLY UNWRAPPED; THE BLADDER WAS NOTED STRETCHED NEAR THE DISTAL END OF THE IABC BLADDER. THE IABC FLEX-TIP ASSEMBLY (PART OF THE IABC CENTRAL LUMEN) NOTED DAMAGED/BROKEN AT APPROXIMATELY 1.5CM FROM THE IABC DISTAL TIP. UNDER THE MICROSCOPIC INSPECTION, SOME POLYIMIDE MATERIAL (PART OF THE FLEX-TIP ASSEMBLY) WAS NOTED WITHIN THE IABC DISTAL TIP. NUMEROUS BENDS TO THE IABC CENTRAL LUMEN WERE NOTED AT APPROXIMATELY 29.9CM, 66.8CM AND 68CM FROM THE IABC LUER END. A KINK TO THE FLEX-TIP ASSEMBLY (PART OF THE IABC CENTRAL LUMEN) WAS NOTED AT APPROXIMATELY 71.3CM FROM THE IABC LUER END. DRIED BLOOD WAS NOTED ON THE EXTERIOR SURFACES OF THE RETURNED SAMPLE. A SMALL AMOUNT OF DRIED BLOOD WAS NOTED WITHIN THE IABC BLADDER. BASED ON THE RETURNED STATE OF THE DEVICE (BLADDER NOTED STRETCHED NEAR THE DISTAL END OF THE IABC BLADDER, SIGNIFICANT DAMAGE NOTED TO THE POLYIMIDE AND THE SMALL AMOUNT OF BLOOD NOTED WITHIN THE IABC BLADDER), THE DAMAGE TO THE IABC FLEX-TIP ASSEMBLY MOST LIKELY OCCURRED DURING OR AFTER THE REMOVAL OF THE DEVICE FROM THE PATIENT. THE BLADDER THICKNESS WAS MEASURED AT SIX POINTS WITH MEASUREMENTS RANGING FROM 0.0055IN-0.0059IN AND WAS WITHIN SPECIFICATION. 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. AN ATTEMPT TO ASPIRATE AND FLUSH THE CATHETER USING A 60CC LAB-INVENTORY SYRINGE WAS UNABLE TO BE SUCCESSFULLY COMPLETED DUE TO A BLOCKED/CLOTTED CENTRAL LUMEN. IMMEDIATE PUSH BACK ON THE SYRINGE PLUNGER WAS EXPERIENCED. THE BLOCKAGE, MOST LIKELY DRIED BLOOD, WAS UNABLE TO BE CLEARED. THE IABC WAS LEAK TESTED AND A LEAK WAS IMMEDIATELY DETECTED FROM THE IABC DISTAL TIP AND LUER END. THE LEAK FROM THE IABC DISTAL TIP AND LUER END ARE CONSISTENT WITH THE BROKEN CENTRAL LUMEN. THE IABC WAS LEAK TESTED AGAIN WITH THE IABC DISTAL TIP AND LUER BLOCKED OFF; NO OTHER LEAKS WERE DETECTED. THE RETURNED 0.025IN GUIDEWIRE WAS BACK LOADED THROUGH THE IABC DISTAL TIP. THE GUIDEWIRE EXITED THE CENTRAL LUMEN AND ENTERED THE BLADDER AT THE LOCATION OF THE DAMAGED/BROKEN CENTRAL LUMEN. NO BLOOD OR DEBRIS WAS NOTED. THE GUIDEWIRE WAS FRONT LOADED THROUGH THE IABC LUER. RESISTANCE WAS NOTED AT APPROXIMATELY 30.1CM FROM THE IABC LUER, WHICH IS THE LOCATION OF THE PREVIOUSLY NOTED BEND. THEN THE GUIDEWIRE COULD NOT ADVANCE AT APPROXIMATELY 67CM FROM THE IABC LUER, WHICH IS THE LOCATION OF THE PREVIOUSLY NOTED BEND AND A POTENTIAL LOCATION OF THE BLOCKED/CLOTTED CENTRAL LUMEN. SOME BLOOD WAS NOTED ON THE GUIDEWIRE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE LOT NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THE REPORTED COMPLIANT OF IAB KINKED IS CONFIRMED. THE INTRA-AORTIC BALLOON CATHETER (IABC) WAS RETURNED WITH A KINK AND MULTIPLE BENDS TO THE CENTRAL LUMEN. ADDITIONALLY, THE CENTRAL LUMEN WAS NOTED DAMAGED/BROKEN NEAR THE IABC DISTAL TIP. THE DAMAGED IABC CAN RESULT IN SIMILAR ALARMS SEEN FROM THE REPORTED COMPLAINT. IT COULD NOT BE CONFIDENTLY DETERMINED WHICH DAMAGE OCCURRED FIRST; HOWEVER, BASED ON THE RETURNED STATE OF THE DEVICE, THE BREAK TO THE CENTRAL LUMEN MOST LIKELY OCCURRED DURING OR AFTER THE REMOVAL OF THE DEVICE FROM THE PATIENT. 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 BENT/KINKED CENTRAL LUMEN. THE ROOT CAUSE OF THE BENT/KINKED CENTRAL LUMEN IS UNDETERMINED. THE MOST PROBABLE POTENTIAL CAUSE IS CUSTOMER HANDLING. NO FURTHER ACTION REQUIRED AT THIS TIME. THIS WILL BE MONITORED FOR ANY DEVELOPING TRENDS. OTHER REMARKS: N/A. CORRECTED DATA: N/A.
IT WAS REPORTED THAT "AFTER 30 MINUTES OF USE, THE MACHINE FREQUENTLY ALARMS AND THE CATHETER MAY BE KINKED. ADJUSTING THE EQUIPMENT AND CATHETER CANNOT SOLVE THE PROBLEM. AFTER REPLACING THE CATHETER, THE PROBLEM WAS RESOLVED". THE 2ND CATHETER WAS INSERTED AT THE SAME INSERTION SITE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".
IT WAS REPORTED THAT "AFTER 30 MINUTES OF USE, THE MACHINE FREQUENTLY ALARMS AND THE CATHETER MAY BE KINKED. ADJUSTING THE EQUIPMENT AND CATHETER CANNOT SOLVE THE PROBLEM. AFTER REPLACING THE CATHETER, THE PROBLEM WAS RESOLVED". THE 2ND CATHETER WAS INSERTED AT THE SAME INSERTION SITE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1182852 | ULTRAFLEX IAB: 7.5FR 30CC | SYSTEM, BALLOON, INTRA-AORTIC | DSP | ARROW INTERNATIONAL LLC | 18F23B0006 | 00801902003751 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Female |