REBAR
Report
- Report Number
- 9612501-2025-00819
- Event Type
- Malfunction
- Date Received
- March 21, 2025
- Date of Event
- February 21, 2025
- Report Date
- October 28, 2025
- Manufacturer
- MEDTRONIC DOMINICANA
- Product Code
- KRA
- PMA / PMN Number
- K093750
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GG
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
PRODUCT ANALYSIS AS FOUND CONDITION: THE PIPELINE FLEX W/ SHIELD DEVICES AND REBAR-27 MICRO CATHETER WERE RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX, WITHIN A SEALED TYVEK BIOHAZARD POUCH, AND WITHIN AN OPENED PIPELINE FLEX W/ SHIELD INNER POUCH. THE PIPELINE FLEX W/ SHIELD DEVICE WAS RETURNED FURTHER WITHIN THE REBAR-27 MICRO CATHETER. VISUAL INSPECTION/DAMAGE LOCATION DETAILS: NO DAMAGES OR IRREGULARITIES WERE FOUND WITH THE REBAR-27 CATHETER HUB. THE PIPELINE FLEX W/ SHIELD PUSHER WAS FOUND EXTENDING OUT THE HUB ~75.8CM. NO DAMAGES OR IRREGULARITIES WERE FOUND WITH THE REBAR-27 MICRO CATHETER BODY OR MARKER BAND. THE DISTAL TIP WAS FOUND DAMAGED (FIGURES D & N). THE PIPELINE FLEX W/ SHIELD DISTAL BRAID AND PORTION OF THE DISTAL DELIVERY WIRE WAS FOUND EXTENDING OUT THE MICRO CATHETER TIP (FIGURE D). THE HYPOTUBE WAS FOUND UNSTRETCHED AND UNDAMAGED WITH THE PTFE SHRINK TUBING STILL INTACT. THE DISTAL DELIVERY WIRE WAS FOUND SEPARATED FROM THE HYPOTUBE PROXIMAL TO THE WIRE WELD (FIGURE K). THE DISTAL DELIVERY WIRE WAS FOUND BROKEN (FIGURES I & J). NO DAMAGES WERE FOUND WITH THE DISTAL MARKER, RE-SHEATHING MARKER OR WITH THE PROXIMAL BUMPER. THE DISTAL AND PROXIMAL DPS RESTRAINTS WERE FOUND TO BE INTACT. THE DPS SLEEVES WERE FOUND INTACT WITH NO SIGNS OF DAMAGE. THE TIP COIL WAS FOUND INTACT. THE DISTAL BRAID WAS FOUND FULLY OPENED, DAMAGED, AND FRAYED (FIGURE E). THE PROXIMAL BRAID END WAS FOUND FULLY TAPERED, DAMAGED AND FRAYED (FIGURE G). TESTING/ANALYSIS: THE REBAR-27 MICRO CATHETER TOTAL LENGTH WAS MEASURED TO BE ~149.2 AND THE USABLE LENGTH WAS MEASURED TO BE ~142.2CM, WHICH IS WITHIN SPECIFICATION. AN IN-HOUSE 0.026¿ MANDREL WAS THEN INSERTED INTO THE REBAR-27 HUB, THROUGH THE MICRO CATHETER BODY, AND OUT THE DISTAL END WITH NO RESISTANCE ENCOUNTERED (FIGURE P). THE RETURNED PIPELINE FLEX W/ SHIELD DEVICE COULD NOT BE USED FOR RESISTANCE TESTING DUE TO THE DAMAGED CONDITION. CONCLUSION: BASED ON THE ANALYSIS FINDINGS, THE CUSTOMER REPORT OF ¿FAILURE/INCOMPLETE OPEN DISTAL (FLEX)¿ COULD NOT BE CONFIRMED; HOWEVER, PROXIMAL BRAID END DID NOT FULLY OPEN. POSSIBLE CAUSES FOR FAILURE TO OPEN FOR EITHER SIDE INCLUDE, BUT NOT LIMITED TO, PATIENT VESSEL TORTUOSITY, DAMAGED BRAID, BRAID IMPROPERLY SIZED TO ANATOMY, BRAID WAS OVERSTRETCHED DURING DELIVERY, USER DEPLOYS BRAID IN VESSEL BRAID, PRESENCE OF OTHER INDWELLING STENTS OR INAPPROPRIATE ANATOMY. THE BRAID WAS FOUND DAMAGED/FRAYED ON BOTH ENDS. POTENTIAL CAUSES FOR BRAID DAMAGE ARE RESHEATHING MORE THAN 2 TIMES, HIGH FORCE DELIVERY, OVER-MANIPULATION, DELIVERING/RETRACTING DELIVERY WIRE AGAINST RESISTANCE, DEPLOYING/RESHEATHING BRAID AGAINST RESISTANCE, OR DAMAGE DURING RETURN SHIPPING AS THE DISTAL BRAID WAS RETURNED ALREADY DEPLOYED AND OUT OF ITS PROTECTIVE INTRODUCER SHEATHS AND DISPENSER COILS. CUSTOMER REPORTED PIPELINE WAS POSITIONED IN A STRAIGHT VASCULATURE, DEVICES WERE PREPARED PER IFU, AND NO PUSHER OR CATHETER DAMAGE WAS OBSERVED. THEREFORE, THE LIKELY CAUSE COULD NOT BE CONFIRMED. THE CUSTOMER REPORT OF ¿STUCK IN CATHETER HUB¿, ¿RESISTANCE DURING RETRIEVAL¿, AND ¿RESISTANCE IN CATHETER¿ WERE CONFIRMED AS THE DAMAGES FOUND ARE CONSISTENT WITH RESISTANCE. IT IS POSSIBLE THE DAMAGED BRAID FOUND CONTRIBUTED TOWARDS THE RESISTANCE. OTHER POSSIBLE CONTRIBUTIONS OF RESISTANCE ARE PATIENT VESSEL TORTUOSITY, USER DOES NOT MAINTAIN CONTINUOUS FLUSH, OR USER PULLS BACK ON/TORQUES WIRE WHILE ADVANCING PED IN MICRO CATHETER. THE DISTAL DELIVERY WIRE WAS FOUND BROKEN AND SEPARATED FROM THE HYPOTUBE, LIKELY CAUSED BY RETRACTING THE DEVICE AGAINST THE REPORTED RESISTANCE. THE DISTAL TIP OF THE MICRO CATHETER WAS FOUND DAMAGED; HOWEVER, THIS DID NOT CONTRIBUTE TOWARDS THE RESISTANCE DURING IN-HOUSE TESTING. THE CUSTOMER REPORT OF ¿MARKER BAND DISLODGED/DAMAGED¿ COULD NOT BE CONFIRMED AS THE MARKER BAND WAS FOUND UNDAMAGED. THE REBAR-27 MICRO CATHETER IS COMPATIBLE FOR USE WITH THE PIPELINE FLEX W/ SHIELD DEVICE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
ADDITIONAL INFORMATION RECEIVED REPORTED THE WHOLE STENT WAS NOT OPENING, EVEN OUTSIDE OF THE BLOOD VESSEL. THE VESSEL WAS STRAIGHT, WITHOUT ANY KINGING. THE STENT MARKER WAS OUT OF A CATHETER, ABOUT 10MM. STILL, IT COULD NOT OPEN. NO PUSH WIRE OR CATHETER DAMAGE WAS OBSERVED. THE PUSH WIRE AND MICROCATHETER WERE STRAIGHT AND IN THE MIDDLE OF THE BLOOD VESSEL. WITHOUT ANY ADDITIONAL PRESSURE. NO ADDITIONAL DEVICES WERE USED.
IT WAS REPORTED THAT DURING A NEUROVASCULAR FLOW DIVERSION PROCEDURE, THE PIPELINE EMBOLIZATION DEVICE 5.00MM X 30MM DID NOT OPEN IN THE VESSEL AND BECAME STUCK IN THE CATHETER WHEN RESHEATHING. IT COULD NOT BE PULLED BACK INTO TH CATHETER. IT COULD MOVE FORWARD. RESISTANCE WAS NOTED IN THE PROXIMAL SECTION OF THE CATHETER, AND THE PIPELINE BECAME STUCK AT THE HUB DURING DEPLOYMENT. DESPITE ATTEMPTS TO RESOLVE THE ISSUE BY RELEASING THE LOAD IN THE SYSTEM, THE PROBLEM PERSISTED. THE PROXIMAL SECTION OF THE CATHETER WAS DAMAGED, AND THE MARKER BAND WAS DISLODGED OR DAMAGED. THE WHOLE SYSTEM WAS REMOVED FROM THE PATIENT. THE ANGIOGRAPHIC RESULT POST-PROCEDURE WAS POSITIVE. THE CATHETER AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE, AND THE CATHETER WAS FLUSHED WITH HEPARINIZED SALINE AS PER INSTRUCTIONS FOR USE (IFU). THE CATHETER AND ACCESSORY DEVICES WILL BE RETURNED FOR EVALUATION. THE PATIENT WAS BEING TREATED FOR ANN UNRUPTURED ANEURYSM. THE DISTAL LANDING ZONE WAS 5MM AND THE PROXIMAL LANDING ZONE WAS 30MM. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 863699 | REBAR | CATHETER, CONTINUOUS FLUSH | KRA | MEDTRONIC DOMINICANA | 105-5082-145 | 0226677223 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |