ASPIREX
Report
- Report Number
- 3008439199-2024-00143
- Event Type
- Malfunction
- Date Received
- August 22, 2024
- Date of Event
- July 26, 2024
- Report Date
- September 27, 2024
- Manufacturer
- STRAUB MEDICAL AG
- Product Code
- DQX
- UDI-DI
- 07640142811350
- PMA / PMN Number
- K220270
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H10: 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: THE CATHETER WAS RETURNED FOR EVALUATION AND WAS PHYSICALLY INVESTIGATED. DURING PHYSICAL INVESTIGATION, THERE WAS A LOT OF BODY MATERIAL IN THE TIP OF THE CATHETER. THE TEST GUIDE WIRE WENT THROUGH WITHOUT ANY RESISTANCE. AFTER RUNNING IN THE WATER ASPIRATION TEST WAS PERFORMED AND NOMINAL ASPIRATION LEVEL WAS ACHIEVED. THE REPORTED MECHANICAL JAM CAN BE CONFIRMED, THE BREAK WAS NOT OBSERVED DURING PHYSICAL INVESTIGATION. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED MECHANICAL JAM ISSUE. 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. H11: D2B (QEW, DQX). 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.
H10: 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: THE CATHETER WAS RETURNED FOR EVALUATION AND WAS PHYSICALLY INVESTIGATED. DURING PHYSICAL INVESTIGATION, THERE WAS A LOT OF BODY MATERIAL IN THE TIP OF THE CATHETER. THE TEST GUIDE WIRE WENT THROUGH WITHOUT ANY RESISTANCE. AFTER RUNNING IN THE WATER ASPIRATION TEST WAS PERFORMED AND NOMINAL ASPIRATION LEVEL WAS ACHIEVED. THE REPORTED MECHANICAL JAM CAN BE CONFIRMED, THE BREAK WAS NOT OBSERVED DURING PHYSICAL INVESTIGATION. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED MECHANICAL JAM ISSUE. 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. EXPIRY DATE: 08/2024. 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.
H10: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE RETURN OF THE SAMPLE IS PENDING. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. H10: D4 (EXPIRY DATE: 08/2024) 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.
IT WAS REPORTED THAT DURING A THROMBECTOMY AND ATHERECTOMY PROCEDURE IN THE EXTERNAL ILIAC VEIN LESION VIA THE COMMON FEMORAL VEIN IPSILATERAL APPROACH, THE DEVICE ALLEGEDLY DID NOT CLUTCH OUT IN THE LESION. IT WAS FURTHER REPORTED THAT THE HELIX OF THE CATHETER ALLEGEDLY BROKE. REPORTEDLY, THE DEVICE WAS TAKEN OUT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
IT WAS REPORTED THAT DURING A THROMBECTOMY AND ATHERECTOMY PROCEDURE IN THE EXTERNAL ILIAC VEIN LESION VIA THE COMMON FEMORAL VEIN IPSILATERAL APPROACH, THE DEVICE ALLEGEDLY DID NOT CLUTCH OUT IN THE LESION. IT WAS FURTHER REPORTED THAT THE HELIX OF THE CATHETER ALLEGEDLY BROKE. REPORTEDLY, THE DEVICE WAS TAKEN OUT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
IT WAS REPORTED THAT DURING A THROMBECTOMY AND ATHERECTOMY PROCEDURE IN THE EXTERNAL ILIAC VEIN LESION VIA THE COMMON FEMORAL VEIN IPSILATERAL APPROACH, THE DEVICE ALLEGEDLY DID NOT CLUTCH OUT IN THE LESION. IT WAS FURTHER REPORTED THAT THE HELIX OF THE CATHETER ALLEGEDLY BROKE. REPORTEDLY, THE DEVICE WAS TAKEN OUT FROM 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 |
|---|---|---|---|---|---|---|---|
| 953406 | ASPIREX | THROMBECTOMY & ATHERECTOMY | DQX | STRAUB MEDICAL AG | 221064 | 07640142811350 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |