ROTAREX
Report
- Report Number
- 3008439199-2025-00205
- Event Type
- Malfunction
- Date Received
- September 3, 2025
- Date of Event
- August 1, 2025
- Report Date
- September 9, 2025
- Manufacturer
- STRAUB MEDICAL AG
- Product Code
- MCW
- PMA / PMN Number
- K211738
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H11: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION AND EVALUATION WAS DONE. HOWEVER, PHOTO WAS PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. D2B: DQX; MCW. SECTION A THROUGH F - THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.
H11: MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS CONDUCTED AND THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. INVESTIGATION SUMMARY: A CATHETER WAS RETURNED FORE EVALUATION AND THE CATHETER WAS PHYSICALLY INVESTIGATED. DURING PHYSICAL INVESTIGATION A CATHETER AND THE COLLECTING BAG ATTACHED TO IT WERE RECEIVED. THE ATTACHED COLLECTING BAG HAD NO ISSUES. THE TEST GUIDE WIRE WENT THROUGH THE CATHETER WITHOUT ANY RESISTANCE TILL THE METAL GEAR WHEEL. THE ASPIRATION TEST WAS PERFORMED, AND NOMINAL ASPIRATION LEVEL WAS ACHIEVED. A CLEAR ROOT CAUSE COULD NOT BE IDENTIFIED BUT A BLOCKAGE OF THE CATHETER REPRESENTS A KNOWN INHERENT RISK. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. D2B: (DQX; MCW), G3, H6 (DEVICE, METHOD, RESULT, CONCLUSION). SECTION A THROUGH F - THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.
ON (B)(6) 2025, A PATIENT UNDERWENT A THROMBECTOMY AND ATHERECTOMY. DURING THE PROCEDURE, IT WAS REPORTED THAT THE ROTAREX CATHETER FAILED TO ADVANCE BEYOND THE EXTERNAL ILIAC WHILE NAVIGATE UPWARDS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING AN ALTERNATIVE DEVICE. THERE WERE NO REPORTED INJURIES TO THE PATIENT.
ON (B)(6) 2025, A PATIENT UNDERWENT A THROMBECTOMY AND ATHERECTOMY. DURING THE PROCEDURE, IT WAS REPORTED THAT THE ROTAREX CATHETER FAILED TO ADVANCE BEYOND THE EXTERNAL ILIAC WHILE NAVIGATE UPWARDS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING AN ALTERNATIVE DEVICE. THERE WERE NO REPORTED INJURIES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2332402 | ROTAREX | THROMBECTOMY & ATHERECTOMY | MCW | STRAUB MEDICAL AG | 250536 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |