MAXCORE
Report
- Report Number
- 2020394-2026-00879
- Event Type
- Malfunction
- Date Received
- April 9, 2026
- Date of Event
- March 18, 2026
- Report Date
- April 10, 2026
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- KNW
- UDI-DI
- 00801741084454
- PMA / PMN Number
- K133948
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H11: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS WAS 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. 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.
H11: MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED, AND THIS LOT MET ALL RELEASE CRITERIA. INVESTIGATION SUMMARY: THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. THREE ELECTRONIC PHOTOS WERE PROVIDED AND REVIEWED. THE FIRST PHOTO SHOWS THAT THE MAXCORE DEVICE IN FULL PRIMED POSITION AND PLACED UPON THE PRODUCT LABEL ALSO THE PRODUCT LABELING INFORMATION OF THE DEVICE WAS SEEN AND VERIFY AND MATCHES WITH THE TRACK WISE DETAILS. THE SECOND PHOTO SHOWS THAT THE MAXCORE DEVICE IN FULL PRIMED POSITION AND PRODUCT LABEL INFORMATION OF THE DEVICE WAS SEEN AND VERIFY AND MATCHES WITH THE TRACK WISE DETAILS. THE THIRD PHOTO SHOWS THAT THE MAXCORE DEVICE IN FULL PRIMED POSITION AND LABEL INFORMATION OF THE DEVICE WAS SEEN AND VERIFY AND MATCHES WITH THE TRACK WISE DETAILS. NO OTHER ANOMALIES WERE NOTED. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED FAILURE AS NO OBJECTIVE EVIDENCE WAS PROVIDED FOR REVIEW. A DEFINITIVE ROOT CAUSE FOR THE REPORTED FAILURE TO FIRE ISSUE COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. 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) 2026, A PATIENT UNDERWENT A COMPUTED TOMOGRAPHY GUIDED KIDNEY BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE USING MAXCORE INSTRUMENT. DURING THE PROCEDURE, THE INSTRUMENT OUTER CANNULA COULD NOT BE FIRED. NO COAXIAL NEEDLE WAS USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
ON (B)(6) 2026, A PATIENT UNDERWENT A COMPUTED TOMOGRAPHY GUIDED KIDNEY BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE USING MAXCORE INSTRUMENT. DURING THE PROCEDURE, THE INSTRUMENT OUTER CANNULA COULD NOT BE FIRED. NO COAXIAL NEEDLE WAS USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 886150 | MAXCORE | BIOPSY INSTRUMENT | KNW | BARD PERIPHERAL VASCULAR, INC. | REKS0840 | 00801741084454 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |