HEMOSTAR
Report
- Report Number
- 3006260740-2024-07813
- Event Type
- Injury
- Date Received
- December 27, 2024
- Date of Event
- July 4, 2014
- Report Date
- February 11, 2025
- Manufacturer
- C.R. BARD, INC. (BASD) -3006260740
- Product Code
- MSD
- PMA / PMN Number
- K190527
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H10: JERZY GARCAREK, EWA WATOREK, JACEK KURCZ, MARIUSZ KUSZTAL, TOMASZ GOLEBIOWSKI, KRZYSZTOF LETACHOWICZ AND ET.AL (2014). ENDOVASCULAR REPARATION OF CENTRAL VEIN INJURY WITH BALLOON-PROTECTED EMBOLIZATION. CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY, 38(4):1057-9. DOI: 10.1007/S00270-014-0945-7. H10: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD.
H10: JERZY GARCAREK, EWA WATOREK, JACEK KURCZ, MARIUSZ KUSZTAL, TOMASZ GOLEBIOWSKI, KRZYSZTOF LETACHOWICZ, ET AL. (2014). ENDOVASCULAR REPARATION OF CENTRAL VEIN INJURY WITH BALLOON-PROTECTED EMBOLIZATION. CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY, 38(4):1057-9. DOI: 10.1007/S00270-014-0945-7. H10: MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUESTED AS THE LOT NUMBER REPORTED IS UNKNOWN. INVESTIGATION SUMMARY: THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. NO PHOTOS WERE PROVIDED FOR REVIEW. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED LEAK, SUCTION PROBLEM AND MIGRATION ISSUES AS NO OBJECTIVE EVIDENCE WAS PROVIDED FOR REVIEW. FURTHERMORE, THE CLINICAL CONDITION ALLEGED IN THE REPORTED EVENT CANNOT BE CONFIRMED. A DEFINITIVE ROOT CAUSE 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. H10: G3. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD.
IT WAS REPORTED IN AN ARTICLE IN THE JOURNAL "CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY" TITLED, "ENDOVASCULAR REPARATION OF CENTRAL VEIN INJURY WITH BALLOON-PROTECTED EMBOLIZATION", THAT IT WAS UNSUCCESSFUL TO DRAW BLOOD, THERE WAS UNUSUAL CATHETER POSITION, SUGGESTING THAT THE CATHETER TIP LEFT INTRAVASCULAR SPACE AND ENTERED MEDIASTINUM. BILATERALLY, THE FLUID IN PLEURAL CAVITIES WAS NOTED. CONTRAST ADMINISTRATION THROUGH THE CATHETER CONFIRMED LEFT INNOMINATE VEIN PERFORATION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
IT WAS REPORTED IN AN ARTICLE IN THE JOURNAL "CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY" TITLED, "ENDOVASCULAR REPARATION OF CENTRAL VEIN INJURY WITH BALLOON-PROTECTED EMBOLIZATION", THAT IT WAS UNSUCCESSFUL TO DRAW BLOOD, THERE WAS UNUSUAL CATHETER POSITION, SUGGESTING THAT THE CATHETER TIP LEFT INTRAVASCULAR SPACE AND ENTERED MEDIASTINUM. BILATERALLY, THE FLUID IN PLEURAL CAVITIES WAS NOTED. CONTRAST ADMINISTRATION THROUGH THE CATHETER CONFIRMED LEFT INNOMINATE VEIN PERFORATION. HOWEVER, THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2495343 | HEMOSTAR | DIALYSIS CATHETER | MSD | C.R. BARD, INC. (BASD) -3006260740 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Female | Required Intervention |