UNKNOWN GROSHONG TITANIUM PORT S/L
Report
- Report Number
- 3006260740-2024-07434
- Event Type
- Malfunction
- Date Received
- December 13, 2024
- Date of Event
- November 19, 2024
- Report Date
- January 16, 2025
- Manufacturer
- C.R. BARD, INC. (BASD) -3006260740
- Product Code
- LJT
- PMA / PMN Number
- UNKNOWN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H10: M. LAUREYS, J. ROMMENS (2007). SPONTANEOUS REPOSITIONING OF A CHEST PORT CATHETER BY CONTRAST MEDIUM INJECTION. CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY. 2007 MAY-JUN;30(3):543-4. DOI: 10.1007/S00270-005-0338-Z. 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 DEVICE HAD SUCTION ISSUE AND CATHETER MIGRATED ISSUE AS NO OBJECTIVE EVIDENCE WAS PROVIDED FOR REVIEW. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE 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.
H10: M. LAUREYS, J. ROMMENS (2007). SPONTANEOUS REPOSITIONING OF A CHEST PORT CATHETER BY CONTRAST MEDIUM INJECTION. CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY. 2007 MAY-JUN;30(3):543-4. DOI: 10.1007/S00270-005-0338-Z. 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.
IT WAS REPORTED IN AN ARTICLE IN THE JOURNAL OF "CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY" TITLED, "SPONTANEOUS REPOSITIONING OF A CHEST PORT CATHETER BY CONTRAST MEDIUM INJECTION", THAT APPROXIMATELY THREE YEARS POST A SINGLE LUMEN GROSHONG CATHETER PLACEMENT THROUGH THE RIGHT JUGULAR VEIN APPROACH FOR CHEMOTHERAPY TREATMENT, THE DEVICE ALLEGEDLY HAD SUCTION ISSUE AND CATHETER MIGRATED. THERE WAS NO REPORTED PATIENT INJURY.
IT WAS REPORTED IN AN ARTICLE IN THE JOURNAL OF "CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY" TITLED, "SPONTANEOUS REPOSITIONING OF A CHEST PORT CATHETER BY CONTRAST MEDIUM INJECTION", THAT APPROXIMATELY THREE YEARS POST SINGLE LUMEN GROSHONG CATHETER PLACEMENT THROUGH THE RIGHT JUGULAR VEIN APPROACH FOR CHEMOTHERAPY TREATMENT, THE DEVICE ALLEGEDLY HAD SUCTION ISSUE AND CATHETER MIGRATED. THERE WAS NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2415418 | UNKNOWN GROSHONG TITANIUM PORT S/L | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR | LJT | C.R. BARD, INC. (BASD) -3006260740 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |