ASPIREX
Report
- Report Number
- 3008439199-2025-00115
- Event Type
- Malfunction
- Date Received
- May 23, 2025
- Date of Event
- April 29, 2025
- Report Date
- July 4, 2025
- Manufacturer
- STRAUB MEDICAL AG
- Product Code
- DQX
- UDI-DI
- 07640142811336
- PMA / PMN Number
- K220270
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H10: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. HOWEVER, PHOTOS WERE PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. H11: D2B (DQX; QEW). H11: 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.
H.11.: 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 WAS RECEIVED. A PHYSICAL INVESTIGATION WAS NOT POSSIBLE. THE USER REPORT AND PROVIDED IMAGE CONTAINS INFORMATION REGARDING CATHETER DETACHMENT. AFTER REVIEW OF THE PROVIDED IMAGES DETACHMENT CAN BE CONFIRMED. A CLEAR ROOT CAUSE FOR THESE INCIDENTS COULD NOT BE IDENTIFIED BUT BREAK OF THE GUIDEWIRE 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; QEW), G2, G3, H6 (COMPONENT, METHOD, RESULT, CONCLUSION). 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.
ON (B)(6) 2025, A PATIENT UNDERWENT A THROMBECTOMY AND ATHERECTOMY PROCEDURE VIA LEFT LOWER ARM USING ASPIREX. DURING THE PROCEDURE, THE HAND SWITCH ALLEGEDLY CAME APART AND THE BREAKAGE OCCUR OUTSIDE OF THE PATIENT BODY. 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 VIA LEFT LOWER ARM USING ASPIREX. DURING THE PROCEDURE, THE HAND SWITCH ALLEGEDLY CAME APART AND THE BREAKAGE OCCUR OUTSIDE OF THE PATIENT BODY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 818665 | ASPIREX | THROMBECTOMY & ATHERECTOMY | DQX | STRAUB MEDICAL AG | 231887 | 07640142811336 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Male |