BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JET PORT PLUS

    MDR report key: 9109271 · Received September 24, 2019

    Report

    Report Number
    9681202-2019-00001
    Event Type
    Malfunction
    Date Received
    September 24, 2019
    Date of Event
    August 8, 2019
    Report Date
    September 24, 2019
    Manufacturer
    PFM MEDICAL CPP SA
    Product Code
    LIT
    PMA / PMN Number
    K072481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED DEVICE IS SIMILAR TO A US MARKET/DISTRIBUTED DEVICE. RESULT OF INVESTIGATION: DEVICE HISTORY RECORD REVIEW: REVISION: 1, DU: (B)(4). THE QUALITY RECORDS FOR THE PORT 61.635.33.075 LOT#: 133148000 ARE COMPLETE AND IN ORDER. NO NON-CONFORMITY WAS RECORDED FOR THIS LOT NUMBER. NO SIMILAR COMPLAINT HAS BEEN RECORDED FOR THIS LOT OF PORTS. THE LOT NUMBER 133148000 IS IDENTIFIED BY MEDICAL DEVICES VIGILANCE SYSTEM BFARM CASE NUMBER: (B)(4) DATED 29.08. 2019. THE PORT 61.635.33.075 LOT# 133148000 WAS MANUFACTURED WITH CATHETER (B)(4) AS PER OHR# (B)(4). THE QUALITY RECORDS FOR THE CATHETER (B)(4) LOT # 851659 USED IN BOTH OHR ARE COMPLETE AND IN ORDER. NO NON-CONFORMITY WAS RECORDED FOR THIS LOT NUMBER. NO SIMILAR COMPLAINT HAS BEEN RECORDED FOR THIS LOT OF CATHETER. INVESTIGATION ON THE RETURNED PRODUCT: ACCORDING TO THE INFORMATION GIVEN BY THE CUSTOMER, THE PORT HAS BEEN IMPLANTED FOR YEARS. THE CATHETER LEAK IS CONFIRMED AT 1/3 OF THE CATHETER LENGTH. CONSIDERING THE TIME OF IMPLANTATION THE CATHETER WAS FUNCTIONAL AT FIRST. BASED ON THE INFORMATION GIVEN BY THE SURGEON AND BASED ON THE SUBSTANTIAL TIME OF IMPLANTATION, WE CAN ASSUME THAT THE LOCALIZATION OF THE CATHETER FRACTURE, AS WELL AS THE SHAPE OF THE DEFECT & THE TIME-TO-DEFECT INDICATE A HIGH PROBABILITY OF A "PINCH-OFF" DEFECT DUE TO A DISPLACEMENT OF THE CATHETER, OR A INCORRECT SURGERY PLACEMENT {PINCH-OFF GRADE3: CATHETER DAMAGE OR BREAKAGE). EXPLANATION: WE SUPPOSE THAT THE CATHETER, INSERTED TO THE LEFT SUBCLAVIAN, WAS COMPRESSED BETWEEN THE FIRST RIB AND THE CLAVICLE. SUCH EFFECT IS VERY WELL DESCRIBED IN THE LITERATURE AND IN OUR INSTRUCTION OF USE. IT IS NAMED "PINCH- OFF". THE RECOMMENDED ACTION FOR A GRADE 3 PINCH-OFF IS THE PROMPT REMOVAL OF THE CATHETER, WHICH WAS FOLLOWED BY THE SURGEON. REVIEW OF RECORDED COMPLAINTS ON THE LAST THREE YEARS {2016-2019): NO COMPLAINT HAS BEEN RECORDED FOR THIS REFERENCE OR TYPE OF PORT. (B)(4) COMPLAINT HAS BEEN RECORDED IN 2016 FOR THIS TYPE OF DEFECT [(B)(4)] WITH CONCLUSION OF PINCH-OFF GRADE 3 DUE TO USE ERROR. BFARM CASE NUMBER (B)(4). REVIEW OF THE RISK ANALYSIS: REVISION : 1, DU: (B)(4). THIS RISK OF A "CATHETER FRACTURE" IS IDENTIFIED IN OUR RISK ANALYSIS (ACCORDING TO (B)(4)). A REVIEW OF OUR COMPLAINTS SHOWED THAT THE MOST FREQUENT CAUSE OF A CATHETER FRACTURE IS A PINCH-OFF GRADE 3. THE REVIEW OF THE INSTRUCTIONS FOR USE SHOWS DETAILED/ADEQUATE INSTRUCTION FOR PORT CATHETER PLACEMENT AND PINCH-OFF WARNING. CONCLUSION: THE COMPLAINT IS JUSTIFIED. WE ASSUME THAT THE REPORTED PROBLEM IS DUE TO A PINCH-OFF GRADE 3. THE MOST FREQUENT CAUSE OF A CATHETER FRACTURE IS PINCH-OFF GRADE 3. THIS RISK IS IDENTIFIED IN OUR RISK ANALYSIS AND SUCH EFFECT IS VERY WELL DESCRIBED IN THE LITERATURE AND IN OUR INSTRUCTION OF USE. [(B)(4).PDF].

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED "PATIENT WITH A PROBLEMATIC PORT CATHETER SYSTEM IMPLANTED FOR YEARS. ACCORDING TO THE PATIENT THE PORT CANNOT BE PROPERLY ASPIRATED, AND ALSO NOT RINSED. ACCORDING TO PATIENT, THE INFUSIONS DID NOT RUN SPONTANEOUSLY OR THEY EVEN RAN PARA. IT WAS IMPLANTED SEVERAL YEARS AGO IN THE V. CEPHALICA WITHOUT ANY PROBLEMS. TODAY I EXP/ANTED THE PORT AND A NEW PORT FROM THE SAME MANUFACTURER ON THE CONTRALATERAL SIDE AT CONTINUED CHEMOTHERAPY INDICATION. DURING THE EXPLANTATION I HAVE A LONG-DISTANCE RUPTURE IN THE INTRAVASCULAR PORTION OF THE CATHETER. THIS FITS VERY WELL TO THE DISCOMFORT THAT THE PATIENT HAS DESCRIBED TO ME. I CONSIDER THIS TO BE A SERIOUS MATERIAL DEFECT. IT IS NOT POSSIBLE THAT SOMEONE COULD MANIPULATE THE INTRAVASCULAR PART OF THE CATHETER; IT IS MUCH MORE LIKELY THAT THE MATERIAL HAD SIMPLY FAILED AND RUPTURED DURING THE RINSING FLUSHING. I THINK THIS IS DANGEROUS, BECAUSE THE 'RINSING FLUSHING' OF CATHETERS IS OFTEN PRACTICED BY ONCOLOGISTS. IF CHEMOTHERAPY WOULD HAVE BEEN ADMINISTERED VIA THIS PORT THERE MIGHT HAVE BEEN SERIOUS TISSUE NECROSIS IN THE PORT POCKET. THE MANUFACTURER HAS BEEN INFORMED. THE PORT WAS KEPT IN MY OFFICE FOR FORENSIC REASONS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907801 JET PORT PLUS INFUSION/INJECTION PORT, IMPLANTABLE LIT PFM MEDICAL CPP SA 61.635.33.075 133148000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other