ASPIREX
Report
- Report Number
- 3008439199-2025-00137
- Event Type
- Malfunction
- Date Received
- June 23, 2025
- Date of Event
- May 28, 2025
- Report Date
- August 19, 2025
- Manufacturer
- STRAUB MEDICAL AG
- Product Code
- DQX
- UDI-DI
- 07640142811336
- PMA / PMN Number
- K220270
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, 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 WILL BE PERFORMED. THE RETURN OF THE SAMPLE IS PENDING. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. D2B (QEW; DQX). SECTION A THROUGH F ¿ THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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 BD.
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: NO PHYSICAL SAMPLE / IMAGES / VIDEOS WERE RECEIVED. A PHYSICAL INVESTIGATION WAS NOT POSSIBLE. DUE TO NO SAMPLE / IMAGES / VIDEOS RECEIVED, THE REPORTED MALFUNCTION CANNOT BE CONFIRMED. 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 (QEW; DQX), G3, H6 (METHOD, RESULT, CONCLUSION). SECTION A THROUGH F: THE INFORMATION PROVIDE BY BD REPRESENTS ALL 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 BD.
ON (B)(6) 2025, A PATIENT UNDERWENT A THROMBECTOMY AND ATHERECTOMY PROCEDURE USING AN 8FR ASPIREX CATHETER. DURING THE PROCEDURE, THE CATHETER ALLEGEDLY BECAME STUCK ON THE WIRE AND COULD NOT BE REMOVED. THEY HAD TO PULL THE ENTIRE DEVICE AND WIRE OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
ON (B)(6) 2025, A PATIENT UNDERWENT A THROMBECTOMY AND ATHERECTOMY PROCEDURE USING AN 8FR ASPIREX CATHETER. DURING THE PROCEDURE, THE CATHETER ALLEGEDLY BECAME STUCK ON THE WIRE AND COULD NOT BE REMOVED. THEY HAD TO PULL THE ENTIRE DEVICE AND WIRE OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 754843 | ASPIREX | THROMBECTOMY & ATHERECTOMY | DQX | STRAUB MEDICAL AG | 241540 | 07640142811336 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |