MARKSMAN
Report
- Report Number
- 9617601-2025-01040
- Event Type
- Malfunction
- Date Received
- August 18, 2025
- Date of Event
- August 14, 2025
- Report Date
- November 3, 2025
- Manufacturer
- MEDTRONIC MEXICO S. DE R.L. DE CV
- Product Code
- KRA
- UDI-DI
- 00847536026261
- PMA / PMN Number
- K091559
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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.
PRODUCT ANALYSIS ¿ AS FOUND CONDITION: THE MARKSMAN CATHETER WAS RETURNED INSIDE A BIOHAZARD BAG AND A SHIPPING BOX. THE PIPELINE FLEX WAS NOT RETURNED. ¿ DAMAGE LOCATION DETAILS: THE CATHETER TIP AND MARKER WERE EXAMINED, AND NO DAMAGE WAS FOUND. THE CATHETER BODY WAS FOUND TO BE FLATTENED FOR A LENGTH OF 3.6 CM TO 18.0 CM FROM THE DISTAL TIP. NO FLASH OR VOIDS WERE MOLDED IN THE HUB. ¿ TESTING/ANALYSIS: THE TOTAL AND USABLE LENGTHS OF THE CATHETER WERE MEASURED TO BE WITHIN SPECIFICATIONS. THE CATHETER WAS FLUSHED WITH WATER, AND WATER EXITED FROM THE DISTAL TIP. THE CATHETER WAS THEN TESTED BY RUNNING AN IN-HOUSE 0.026¿ MANDREL THROUGH THE CATHETER HUB. THE MANDREL SUCCESSFULLY PASSED THROUGH THE CATHETER HUB WITHOUT ISSUES; HOWEVER, RESISTANCE WAS OBSERVED AT THE DAMAGED LOCATIONS. ¿ CONCLUSION: BASED ON THE RETURNED DEVICE, THE CUSTOMER'S COMPLAINT WAS CONFIRMED AS THE RETURNED CATHETER WAS FOUND FLATTENED. IT IS POSSIBLE THAT THE DAMAGE OCCURRED WHEN THE CUSTOMER ATTEMPTED TO ADVANCE THE PIPELINE FLEX SHIELD THROUGH THE CATHETER AGAINST THE RESISTANCE. HOWEVER, THE CAUSE OF THE DAMAGE AND RESISTANCE COULD NOT BE DETERMINED. POSSIBLE CAUSES OF RESISTANCE INCLUDE THE USE OF A DAMAGED DEVICE, VESSEL TORTUOSITY, AND A LACK OF CONTINUOUS FLUSHING DURING DELIVERY. HOWEVER, THE CUSTOMER REPORTED THAT THE VESSEL TORTUOSITY WAS MODERATE, AND A CONTINUOUS FLUSH WAS USED DURING DELIVERY, WHICH RULES THESE OUT AS POTENTIAL CAUSES. SINCE THE PIPELINE FLEX WAS NOT RETURNED, ANY CONTRIBUTION OF THE PIPELINE FLEX TO THE RESISTANCE ISSUE COULD NOT BE DETERMINED. 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.
MEDTRONIC RECEIVED A REPORT THAT AFTER THE PATIENT UNDERWENT PREPARATORY ANGIOGRAPHY AND 3D ANGIOGRAPHY, THE DIAGNOSIS WAS MADE (A LEFT C7 POSTERIOR COMMUNICATING ARTERY ANEURYSM, SACCULAR IN SHAPE, 4.7MM X 2.3MM). FIRST, THE LONG SHEATH WAS ADVANCED TO THE ORIGIN OF THE C1 SEGMENT USING A LONG, SINGLE-BEND LOACH GUIDEWIRE. THEN THE LOACH GUIDEWIRE WAS WITHDRAWN, AND THE INTERMEDIATE CATHETER (5F INTRACRANIAL SUPPORT CATHETER NAVIEN RFX058-115-08, LOT NUMBER: B756846) WAS ADVANCED TO THE OPENING OF THE LONG SHEATH (ORIGIN OF THE C1 SEGMENT). THEN THE LOACH GUIDEWIRE WAS ADVANCED TO THE C4 SEGMENT. ONCE THE INTERMEDIATE CATHETER (5F INTRACRANIAL SUPPORT CATHETER NAVIEN RFX058-115-08, LOT NUMBER: B756846) WAS IN PLACE, BECAUSE THE ANEURYSM HAD A SMALL DAUGHTER SAC, A MICROGUIDEWIRE (AVIGAO 106-0606-200, LOT NUMBER: B813420) AND A COIL MICROCATHETER (ECHELON¿ 10 145-5091-150, LOT NUMBER: 0230742183) WAS DELIVERED TO THE ANEURYSM BODY. THEN, A COIL (DETACHABLE COIL APB-2.5-4-3D-ES, LOT NUMBER: 229115258) WAS FILLED IN THE ANEURYSM. THE COIL FORMED A HOOP AND IT WAS STABLE, SHOWED NO SIGNS OF PULSATION. THE COIL WAS THEN DETACHED, THE COIL HAD NO SIGNS OF PULSATION OR ESCAPE, AND THE MICROCATHETER WAS WITHDRAWN. THEN, A STENT CATHETER (MARKSMAN FA-55150-1030, LOT NUMBER: 229237825) WAS ADVANCED TO THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY OVER A MICROGUIDEWIRE (AVIGO 103-0606-200, LOT NUMBER: B813420). THEN, THE FLOW-DIVERTING DENSE MESH STENT (PIPELINE¿ FLEX PED-450-16 LOT NUMBER: B810898) WAS OPENED AND HYDRATED. AFTER HYDRATION, THE BLOOD FLOW WAS SLOWLY DIRECTED THROUGH THE MICROCATHETER INTO THE STENT CATHETER. WHEN THE MICROCATHETER REACHED THE C6 INTERNAL CAROTID ARTERY, IT WAS VERY STIFF, AND THE SURGEON STRUGGLED TO PUSH IT. THE SURGEON PUSHED AND PULLED THE CATHETER BACK AND FORTH TWICE BUT FOUND SIGNIFICANT RESISTANCE. THE SURGEON THEN WITHDREW THE CATHETER, REPLACED IT WITH A NEW STENT, AND RESUMED THE OPERATION. UNDER THE SURGEON'S GUIDANCE, THE STENT WAS FINALLY ADVANCED TO THE M2 SEGMENT OF THE BRAIN, AND THE STENT TIP WAS SLOWLY DEPLOYED. HOWEVER, THE DEPLOYMENT PROCESS WAS ALSO VERY LABORIOUS, REQUIRING FOUR BACK-AND-FORTH MANEUVERS BEFORE THE STENT TIP WAS SLOWLY DEPLOYED. THE STENT WAS THEN SLOWLY DRAGGED TO THE T-BIFURCATION IN THE FRONT AND MIDDLE OF THE BRAIN, AND THEN THE STENT WAS SLOWLY DEPLOYED. AFTER THE STENT WAS DEPLOYED, IT WAS NOT COMPLETELY ATTACHED THE WALL, SO MASSAGE WITH A MICROGUIDEWIRE AND MICROCATHETER WAS PERFORMED. THE STENT ADHERED WELL TO THE WALL, AND THE SURGERY WAS ULTIMATELY SUCCESSFUL AND ENDED SAFELY. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS ALIVE WITH NO INJURY. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THERE WAS CATHETER RESISTANCE IN THE DISTAL SECTION. THE PATIENT WAS UNDERGOING SURGERY FOR INTRACRANIAL ANEURYSM TREATMENT. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE RIGHT FEMORAL ARTERY WITH A DIAMETER OF 7MM.
ADDITIONAL INFORMATION WAS RECEIVED. THERE WAS RESISTANCE DURING DEPLOYMENT, BUT THE CAUSE OF THE RESISTANCE AND THE DIFFICULT DEPLOYMENT/WALL APPOSITION COULD NOT BE CONFIRMED. RESISTANCE OCCURRED IN THE DISTAL SECTION OF THE CATHETER. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. NO DAMAGE WAS OBSERVED ON THE PIPELINE PUSHWIRE OR CATHETER. THE DISTAL SECTION OF THE PIPELINE DID NOT OPEN. THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. THE DEVICE WAS RETRIEVED AND REDEPLOYED. NO ISSUES WERE REPORTED WITH OTHER MEDTRONIC DEVICES APART FROM THE MARKSMAN AND PIPELINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2043958 | MARKSMAN | CATHETER, CONTINUOUS FLUSH | KRA | MEDTRONIC MEXICO S. DE R.L. DE CV | FA-55150-1030 | 229237825 | 00847536026261 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Female |