POWERPORT MRI 8GS, INT. W SP, ATT S/L
Report
- Report Number
- 3006260740-2024-03785
- Event Type
- Injury
- Date Received
- July 15, 2024
- Date of Event
- May 6, 2022
- Report Date
- August 21, 2024
- Manufacturer
- C.R. BARD, INC. (BASD) -3006260740
- Product Code
- LJT
- UDI-DI
- 00801741027246
- PMA / PMN Number
- K063377
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- 003
Narratives
H10: MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUIRED AS THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS PRODUCT AND LOT. INVESTIGATION SUMMARY: THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. THE MEDICAL RECORDS ALLEGE THAT, A PATIENT UNDERWENT PORT PLACEMENT PROCEDURE FOR TREATMENT OF RIGHT BREAST INVASIVE DUCTAL CARCINOMA. A SUBCUTANEOUS POCKET WAS CREATED FOR THE PORT AND THE CATHETER WAS TUNNELED TO THE SUBCUTANEOUS POCKET. THE CATHETER WAS ASSESSED, AND IT FLUSHED AND ASPIRATED EASILY. PORTABLE CHEST X-RAY WAS OBTAINED IN THE RECOVERY ROOM WHICH DID NOT DEMONSTRATE A PNEUMOTHORAX. THE CATHETER TIP APPEARED TO BE IN THE SUPERIOR ASPECT OF THE SUPERIOR VENA CAVA. AFTER ONE MONTH FIVE DAYS LATER, PATIENT UNDERWENT FLUOROSCOPIC GUIDED CATHETER CHECK FOR MALFUNCTIONING MEDIPORT. THE STUDY SHOWED OPACIFICATION OF THE MEDIPORT HUB AND PROXIMAL CATHETER. THE MIDPORTION OF THE CATHETER IS FRACTURED UNDER THE EDGE OF THE CLAVICLE WITH THE REMAINDER OF THE CATHETER OVERLYING THE UPPER PORTION OF THE HEART, PERHAPS WITHIN THE PULMONARY ARTERY. CONTRAST DOES NOT EXTEND INTO THE VESSEL, DUE TO WITHDRAWAL OF THE PROXIMAL FRACTURED PORTION. ON THE SAME DAY PATIENT UNDERWENT X-RAY FLUOROSCOPY RETRIEVAL OF PORT CATHETER AND PLACEMENT OF NEW PORT. THE PIGTAIL CATHETER WAS UTILIZED TO ENGAGE THE FRACTURED PORT CATHETER WITHOUT SUCCESS. THE BENTSON CATHETER WAS UTILIZED TO ASSOCIATE THE LEFT MAIN PULMONARY ARTERY. THE ENSNARE RETRIEVAL DEVICE WAS UTILIZED TO RETRIEVE THE FRACTURED PORT CATHETER. THE FRACTURED PORT CATHETER WAS REMOVED IN ITS ENTIRETY THROUGH THE VASCULAR ACCESS SHEATH. UNDER ULTRASOUND GUIDANCE, A PATENT LEFT INTERNAL JUGULAR VEIN WAS ACCESSED AND A SPOT ULTRASOUND IMAGE WAS OBTAINED. WITH GENTLE TRACTION AND BLUNT DISSECTION, THE FRACTURED PORT WAS REMOVED IN ITS ENTIRETY. A NEW PORT CATHETER WAS TUNNELED BENEATH THE SUBCUTANEOUS TISSUES AND PLACED VIA A PEEL AWAY SHEATH. THE DISTAL TIP OF THE PORT CATHETER IS POSITIONED AT THE CAVAL ATRIAL JUNCTION. THE PORT CATHETER FLUSHED AND ASPIRATED FREELY. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED DEFICIENCY AS PER THE SUBMITTED MEDICAL RECORD REVIEW. ADDITIONALLY, IT CAN BE CONFIRMED THAT THE PATIENT EXPERIENCED MIGRATION, FRACTURE, FLUID LEAK AND MATERIAL SEPARATION. HOWEVER, THE RELATIONSHIP TO THE PORT IS UNKNOWN. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. H10: D4 (EXPIRATION DATE: 03/2025), G3, H6(METHOD) H11: H6(RESULT, CONCLUSION) 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: ADDITIONAL INFORMATION WAS RECEIVED, AND THE FILE WAS REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE AS SERIOUS INJURY. 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. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. H10: D4 (EXPIRY DATE: 03/2025). 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: 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 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 THROUGH LITIGATION PROCESS THAT APPROXIMATELY ONE MONTH AND THIRTEEN DAYS LATER POST PORT PLACEMENT FOR THE CHEMOTHERAPY TREATMENT, THE PORT CATHETER ALLEGEDLY HAD FRACTURE, FLUID LEAK AND THE FRACTURED CATHETER MIGRATED INTO THE MAIN PULMONARY ARTERY. REPORTEDLY, THE FRACTURED CATHETER AND THE PORT WAS REMOVED AND NEW PORT HAS BEEN IMPLANTED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
IT WAS REPORTED THROUGH LITIGATION PROCESS THAT APPROXIMATELY ONE MONTH AND THIRTEEN DAYS LATER POST PORT PLACEMENT FOR THE CHEMOTHERAPY TREATMENT, THE PORT CATHETER ALLEGEDLY HAD FRACTURE, FLUID LEAK AND THE FRACTURED CATHETER MIGRATED INTO THE MAIN PULMONARY ARTERY. REPORTEDLY, THE FRACTURED CATHETER AND THE PORT WAS REMOVED AND NEW PORT HAS BEEN IMPLANTED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE CATHETER WAS ALLEGEDLY FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2517929 | POWERPORT MRI 8GS, INT. W SP, ATT S/L | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR | LJT | C.R. BARD, INC. (BASD) -3006260740 | REFZ3163 | 00801741027246 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Female | Required Intervention |