ARROW FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
Report
- Report Number
- 3010532612-2023-00606
- Event Type
- Malfunction
- Date Received
- October 31, 2023
- Date of Event
- October 11, 2023
- Report Date
- October 11, 2023
- Manufacturer
- ARROW INTERNATIONAL LLC
- Product Code
- DSP
- UDI-DI
- 00801902007247
- PMA / PMN Number
- K021462
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4).
QN # (B)(4). THE REPORTED COMPLAINT FOR "MALFUNCTIONING IAB 40CC FIBEROPTIX CATHETER" WAS CONFIRMED UPON THE INVESTIGATION OF THE RETURNED SAMPLE. THE CUSTOMER RETURNED A 40CC 8.0FR FOS INTRA-AORTIC BALLOON CATHETER (IABC) WITHOUT THE ORIGINAL PACKAGING FOR INVESTIGATION. THE SAMPLE WAS RETURNED IN A SHIPPING ENVELOPE AND WAS IN A SEALED BIO-HAZARD BAG (INP-1, INP-2). UPON RETURN, THE PEEL AWAY SHEATH WAS NOTED ON THE RETURNED IABC (INP-4). THE ONE-WAY VALVE WAS CONNECTED AND TETHERED TO THE SHORT DRIVELINE TUBING (INP-5). THE BLADDER WAS FULLY WRAPPED (INP-6). BENDS WERE NOTED TO THE IABC AT APPROXIMATELY 5.8CM, 15.0CM, 36.4CM, 56.5CM, AND 72.5CM FROM THE IABC DISTAL TIP (INP-7 THROUGH INP-10). A FEW SPOTS OF DRIED BLOOD WERE NOTED ON THE EXTERIOR OF THE IABC. NO BLOOD WAS NOTED WITHIN THE HELIUM PATHWAY. THE FOS CONNECTOR AND CAL KEY WERE EXAMINED. THE FOS GRAY CONNECTER WAS RECESSED IN THE BLUE CLAMSHELL HOUSING AND BOTH RETAINING TABS WERE INTACT (INP-11, INP-12, AND INP-13). THE CENTER POST OF THE FOS WAS CENTERED. THE BLUE CLAMSHELL HOUSING WAS EXAMINED, AND NO DAMAGE WAS NOTED. THE CAL KEY WAS INTACT. THE CAL KEY WAS EXAMINED, AND NO DAMAGE WAS NOTED (INP-14, INP-15). THE CAL KEY CODE IS "0174" (INP-14). 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 ACCORDING TO QUALITY SYSTEM DOCUMENT. THE CAL KEY AND FOS WERE CONNECTED TO THE IABP. THE FOS CONNECTOR WAS NOT RECOGNIZED UPON CONNECTION BECAUSE OF THE RECESSED FOS CONNECTOR. USING LAB INVENTORY FORCEPS, THE GRAY FOS CONNECTOR WAS HELD IN PLACE. THE PUMP DISPLAYED "FOS SENSOR CONNECTED, CONNECT CAL KEY TO ZERO" AND DISPLAYED FOS STATUS "CK" (CAL KEY), INDICATING THAT THE CAL KEY WAS NOT RECOGNIZED BY THE IABP (ANP-1, ANP-2). THE CAL KEY WAS REMOVED AND ROTATED 180 DEGREES AND THEN REINSERTED WITH THE SAME RESULT. THE FOS CAL KEY WAS VISUALLY INSPECTED AGAIN, AND NO DAMAGE WAS NOTED. THE FOS COULD NOT BE AUTOZEROED BY THE PUMP DUE TO THE UNRECOGNIZED CAL KEY. UPON FURTHER INSPECTION, THE FOS FIBER WAS FOUND FULLY INTACT. THE CATHETER'S CENTRAL LUMEN WAS SUCCESSFULLY ASPIRATED AND FLUSHED USING A 60CC LAB-INVENTORY SYRINGE. NO BLOOD OR DEBRIS WAS NOTED. THE IABC WAS LEAK TESTED IN ACCORDANCE WITH TESTING METHODS FROM MANUFACTURING PROCEDURE. NO LEAKS WERE DETECTED. FULL INFLATION WAS ACHIEVED. THE DEVICE PASSED THE LEAK TEST. A LAB INVENTORY 0.025IN GUIDEWIRE WAS BACK LOADED THROUGH THE IABC DISTAL TIP. THE GUIDEWIRE MET RESISTANCE AT APPROXIMATELY 6.1CM; THE GUIDEWIRE COULD NOT ADVANCE AT APPROXIMATELY 36.4CM FROM THE IABC DISTAL TIP DUE TO A PREVIOUSLY NOTED BEND. NO BLOOD OR DEBRIS WAS NOTED. THE GUIDEWIRE WAS FRONT LOADED THROUGH THE IABC LUER. RESISTANCE WAS NOTED A T APPROXIMATELY 9.8CM FROM THE IABC LUER, AND THE GUIDEWIRE COULD NOT ADVANCE AT APPROXIMATELY 46.0CM FROM THE IABC LUER DUE TO A PREVIOUSLY NOTED BEND. NO BLOOD OR DEBRIS WAS NOTED. 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 RECESSED FOS CONNECTOR AND CAL KEY NOT RECOGNIZED. THE ROOT CAUSE OF THE RECESSED FOS CONNECTOR WAS UNDETERMINED. THE ROOT CAUSE OF THE CAL KEY ISSUE IS SUPPLIER RELATED. FURTHER INVESTIGATION HAS BEEN INITIATED UNDER TELEFLEX'S QUALITY SYSTEM BY THE MANUFACTURING SITE TO FURTHER INVESTIGATE THE ISSUE RELATED TO THE CAL KEY NOT RECOGNIZED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE. OTHER REMARKS: N/A CORRECTED DATA: N/A.
QN# (B)(4). IN SECTION D PROVIDED THE FULL UDI # **UDI RELATED DATA QUALITY UPDATES ONLY** OTHER REMARKS: N/A. CORRECTED DATA: N/A.
IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, "THE TRANSDUCER IS MALFUNCTIONING". THE USER WAS UNSURE IF IT WAS THE CENTRAL LUMEN OR THE FIBEROPTIC CATHETER. AS A RESULT, THE IAB WAS REMOVED AND A 2ND IAB WAS INSERTED AT THE SAME INSERTION SITE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".
IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, "THE TRANSDUCER IS MALFUNCTIONING". THE USER WAS UNSURE IF IT WAS THE CENTRAL LUMEN OR THE FIBEROPTIC CATHETER. AS A RESULT, THE IAB WAS REMOVED AND A 2ND IAB WAS INSERTED AT THE SAME INSERTION SITE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".
IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, "THE TRANSDUCER IS MALFUNCTIONING". THE USER WAS UNSURE IF IT WAS THE CENTRAL LUMEN OR THE FIBEROPTIC CATHETER. AS A RESULT, THE IAB WAS REMOVED AND A 2ND IAB 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 |
|---|---|---|---|---|---|---|---|
| 2113317 | ARROW FIBEROPTIX ULTRA 8 IAB: 8FR 40CC | SYSTEM, BALLOON, INTRA-AORTIC | DSP | ARROW INTERNATIONAL LLC | 18F23A0026 | 00801902007247 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |