ARROW PERCUTANEOUS THROMBOLYTIC DEVICE KIT
Report
- Report Number
- 9680794-2018-00037
- Event Type
- Malfunction
- Date Received
- February 14, 2018
- Date of Event
- February 2, 2018
- Report Date
- February 6, 2018
- Manufacturer
- ARROW INTERNATIONAL INC.
- Product Code
- DXE
- PMA / PMN Number
- K011056
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER
Narratives
(B)(4).
QN# (B)(4). THE CUSTOMER RETURNED A 7FR PTD CATHETER AND A PTD ROTATOR FOR EVALUATION. THE RETURNED CATHETER HAD EVIDENCE OF USE IN THE FORM OF DRIED BLOOD. THE CUSTOMER REPORTED THAT THE "MIDDLE OF THE CATHETER WAS CUT OFF"; HOWEVER, THE PTD CATHETER BODY OF THE RETURNED DEVICE APPEARED TO BE INTACT AND NO DAMAGE TO THE CATHETER BODY OR PTD CABLE WAS OBSERVED. HOWEVER, ONE OF THE PTD BASKET WIRES WAS BROKEN ON THE RETURNED SAMPLE. VISUAL INSPECTION REVEALED THAT THE BASKET WIRE WAS DETACHED FROM THE PROXIMAL CONNECTOR. ALL FOUR OF THE WIRES WERE SECURED TO THE DISTAL CONNECTOR. MICROSCOPIC EXAMINATION REVEALED THE CONNECTOR WELDS ARE COMPLETE WITHOUT VOIDS. THE ENDS OF BOTH BROKEN BASKET WIRES WERE JAGGED INDICATING A TEAR. THE ORANGE LUMEN WAS PRESENT, BUT IT WAS DEFORMED ADJACENT TO THE PROXIMAL CONNECTOR AND WAS ABLE TO BE REMOVED FROM THE CONNECTOR BY HAND. THE PTD CATHETER BODY WAS INSPECTED AND NO KINKS/DAMAGE/ANOMALIES WERE OBSERVED ON THE CATHETER BODY OR THE PTD CABLE. THE PTD CATHETER WAS INSPECTED WITH THE BASKET RETRACTED AND WITH THE BASKET ADVANCED AND NO DEFECTS WERE OBSERVED. THE PEBAX BASKET TIP MEASURED 0.61" WHICH IS WITHIN SPECIFICATION. THEREFORE THE ENTIRE TIP APPEARS TO BE INTACT. OTHER REMARKS: THE PTD CATHETER WAS PLACED INTO THE RETURNED ROTATOR TO FUNCTIONALLY TEST THE DEVICE. THE PTD BASKET ROTATED AS EXPECTED WHEN THE ACTIVATION BUTTON WAS PRESSED, INDICATING THE PTD CATHETER WAS INTACT AND FUNCTIONING PROPERLY. A MANUAL TUG ON THE THREE INTACT WIRES REVEALED THAT THEY WERE SECURED TO THE PROXIMAL CONNECTOR ASSEMBLY. ALL FOUR WIRES WERE SECURED TO THE DISTAL CONNECTOR ASSEMBLY. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE PTD CATHETER AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE INSTRUCTIONS-FOR-USE (IFU) PROVIDED WITH THIS PRODUCT PROVIDES WARNINGS THAT THE CATHETER ASSEMBLY IS NOT TO BE ADVANCED FORWARD DURING ACTIVATION AND NOT TO ADVANCE THE DEVICE BEYOND THE ANASTOMOSIS. THE IFU ALSO WARNS THAT POTENTIAL FATIGUE FAILURE OF THE TORQUE CABLE AND FRAGMENTATION BASKET MAY OCCUR WITH PROLONGED ACTIVATION AND THE CUMULATIVE ACTIVATION TIME OF THE PTD DEVICE IN ALL RADII SHOULD BE LIMITED TO 30-60 SECONDS. A RAPID WITHDRAWAL RATE OF 1-2 CM/SECOND IS RECOMMENDED WHEN SHARP RADII ARE ENCOUNTERED. THE CUSTOMER REPORTED A DAMAGED PTD CATHETER BODY; HOWEVER, THE SAMPLE RETURNED HAD A BASKET WIRE BROKEN OUT OF THE CONNECTOR (CATHETER BODY WAS UNDAMAGED). ONE BASKET WIRE WAS DISCONNECTED FROM THE PROXIMAL BASKET CONNECTOR. THE INVESTIGATION AND A DEVICE HISTORY RECORD REVIEW FOUND NO EVIDENCE TO INDICATE A MANUFACTURING RELATED ISSUE. BASED ON THE DAMAGE OBSERVED TO THE BASKET ASSEMBLY AND THE TIME OF OCCURRENCE, IT WAS DETERMINED THAT OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THIS EVENT.
THE CUSTOMER ALLEGES THE MD WAS PERFORMING THE PROCEDURE ACCORDING TO THE IFU. THEN THE MIDDLE OF THE CATHETER WAS CUT OFF. THEREFORE, MD COULD NOT PROCEED WITH THE PRODUCT, AND THE SAME PRODUCT WAS USED WITHOUT ANY ABNORMALITY.
THE CUSTOMER ALLEGES THE MD WAS PERFORMING THE PROCEDURE ACCORDING TO THE IFU. THEN THE MIDDLE OF THE CATHETER WAS CUT OFF. THEREFORE, MD COULD NOT PROCEED WITH THE PRODUCT, AND THE SAME PRODUCT WAS USED WITHOUT ANY ABNORMALITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 113416 | ARROW PERCUTANEOUS THROMBOLYTIC DEVICE KIT | CATHETER, EMBOLECTOMY | DXE | ARROW INTERNATIONAL INC. | 13F16E0093 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |