BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1820334-2018-03494

    MDR report key: 8129768 · Received December 4, 2018

    Report

    Report Number
    1820334-2018-03494
    Event Type
    Injury
    Date Received
    December 4, 2018
    Report Date
    February 12, 2019
    Manufacturer
    COOK INC
    Product Code
    GBX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION - EVALUATION. A REVIEW OF THE COMPLAINT HISTORY, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    SUSPECT MEDICAL DEVICE: PRODUCT DESCRIBED AS A 14F DAWSON-MUELLER G/GJ CATHETER WITH A LOCKING LOOP. SPECIFIC DEVICE INFORMATION WAS UNABLE TO BE DETERMINED. CONCOMITANT PRODUCTS: UNSPECIFIED GASTROPEXY SUTURES, UNSPECIFIED NASOGASTRIC TUBE OR 5F COOK KUMPHE CATHETER. PMA/510(K) #: SPECIFIC PRODUCT INFORMATION UNKNOWN. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    THE BELOW DESCRIPTION OF CATHETER MAINTENANCE ISSUES WAS FOUND IN THE FOLLOWING ARTICLE: OWEN O'CONNOR, ELIZABETH DIVER, SHAUNAGH MCDERMOTT, ET AL. "PALLIATIVE GASTROSTOMY IN THE SETTING OF VOLUMINOUS ASCITES." J PALLIAT MED 17.7 (2014): 811-821. THE ARTICLE DESCRIBES A RETROSPECTIVE REVIEW OF IMAGING, PROCEDURE DETAILS, OUTCOMES, AND COMPLICATIONS OF PERCUTANEOUS GASTROSTOMY/GASTROJEJUNOSTOMY (G/GJ) IN PATIENTS WITH VOLUMINOUS ASCITES. THE G/GJ CATHETER TYPICALLY USED WAS A 14F DAWSON-MUELLER CATHETER WITH A LOCKING LOOP. SIXTY-SIX PRIMARY G AND THREE PRIMARY GJ INSERTIONS WERE PERFORMED DURING THE STUDY (69 PATIENTS: 14 MALE, 55 FEMALE, MEAN AGE 58 ¿ 12 YEARS, RANGE 32¿89 YEARS). ALMOST 90% OF PATIENTS HAD ASCITES DUE TO A MALIGNANT DISEASE. MOST INSERTIONS IN PATIENTS WITH MALIGNANT DISEASE WERE TO RELIEVE SMALL BOWEL OBSTRUCTION. INSERTIONS IN PATIENTS WITH BENIGN DISEASE WERE FOR FEEDING (MOST COMMONLY DUE TO CIRRHOSIS WITH NEUROLOGICAL IMPAIRMENT). DEVICES WERE PLACED UNDER FLUOROSCOPIC OR CT GUIDANCE. DUE TO PATIENT CONDITIONS, TEN PATIENTS DIED IN THE HOSPITAL AFTER INSERTION (PER THE AUTHOR, "THESE OTHER PATIENTS DIED OUTSIDE THE PERIPROCEDURAL REFERENCE PERIOD OF ONE MONTH. THESE PATIENTS DIED AS A RESULT OF THEIR CANCER. THEY WERE INCLUDED IN THE SURVIVAL ANALYSIS (WHICH UNFORTUNATELY WAS VERY SHORT FOR MOST OF THESE PATIENTS DUE TO THE NATURE OF THEIR DISEASE)¿). THE AVERAGE SURVIVAL TIME AVAILABLE FOR THE REMAINING PATIENTS WAS 43 DAYS AFTER INSERTION. THERE WERE 28 MAJOR COMPLICATIONS REPORTED AFTER G/GJ INSERTION. THIS MEDWATCH REPORT (1820334-2018-03494) RECORDS ONE (B)(6) FEMALE WHO EXPERIENCED HEMATEMESIS FOLLOWING G TUBE INSERTION. THIS PATIENT HAD SMALL BOWEL OBSTRUCTION, ASCITES, AND PERITONEAL CARCINOMATOSIS DUE TO COLON CARCINOMA. AFTER HEMATEMESIS, CONTRAST INJECTION WAS PERFORMED TO CONFIRM ADEQUATE PLACEMENT. THE LOCKING LOOP WAS SHOWN TO HAVE ENTRAPPED A FOLD OF GASTRIC MUCOSA ON G TUBE AND THERE WAS AN ISCHEMIC ULCER IN THE MUCOSAL FOLD THAT WAS BELIEVED RESPONSIBLE FOR THE HEMATEMESIS. THE G TUBE WAS ADVANCED AND THE MUCOSA RELEASED. SUBSEQUENT CT CONFIRMED ADEQUATE G TUBE PLACEMENT. THE OTHER COMPLICATIONS INCLUDE THIRTEEN TUBES THAT FELL OUT, TWELVE OF WHICH OCCURRED IN UNSPECIFIED PATIENTS AND ARE RECORDED UNDER MEDWATCH REPORT #1820334-2018-03552. THE THIRTEENTH TUBE DISLODGEMENT OCCURRED IN ONE (B)(6) PATIENT WITH OVARIAN CARCINOMA, ASCITES, AND SMALL BOWEL OBSTRUCTION. THIS PATIENT COMPLICATION IS RECORDED UNDER MEDWATCH REPORT #1820334-2018-03553. SIX PATIENTS EXPERIENCED LEAKAGE, FIVE OF WHICH WERE UNSPECIFIED AND ARE RECORDED UNDER MEDWATCH REPORT #1820334-2018-03554. ONE LEAKAGE PATIENT WAS STATED TO ALSO EXPERIENCE SKIN EXCORIATION DUE TO LEAKAGE. THIS PATIENT REQUIRED DIRECT TREATMENT TO TREAT THE EXCORIATION AND IS RECORDED UNDER MEDWATCH REPORT #1820334-2018-03486. FOUR TUBES REQUIRED REPOSITIONING WITHIN THE STOMACH RESULTING IN A REPOSITIONING PROCEDURE, THREE OF WHICH ARE UNSPECIFIED AND ARE RECORDED UNDER MEDWATCH REPORT #1820334-2018-03491. ONE REPOSITIONING PROCEDURE OCCURRED IN DUE TO LEAKAGE IN A (B)(6) FEMALE AND IS RECORDED UNDER MEDWATCH REPORT #1820334-2018-03492. ONE (B)(6) FEMALE EXPERIENCED TUBE OCCLUSION 10 DAYS AFTER INSERTION AND IS RECORDED UNDER MEDWATCH REPORT #1820334-2018-03493. IT WAS ALSO REPORTED THAT ONE PATIENT EXPIRED DUE TO FAILED GASTROPEXY. THE FAILED GASTROPEXY RESULTED IN PERITONEAL LEAKAGE AND SEPSIS. THIS EVENT WAS NOTED TO BE UNRELATED TO THE TYPE OF CATHETER BY THE PHYSICIAN UPON FURTHER QUESTIONING. IT IS STATED THESE ISSUES RESULTED IN ADDITIONAL PROCEDURES SUCH AS CATHETER REPLACEMENT, REPOSITIONING, AND/OR INCREASED THE LEVEL OF CARE THAT THE PATIENTS REQUIRED. PER CORRESPONDENCE WITH THE AUTHOR, THESE ISSUED WERE GENERALLY TREATED WITHOUT ADVERSE EFFECT. ADDITIONALLY, PER THE AUTHOR, " I DON¿T HAVE DATA ON THE INDIVIDUAL PATIENTS ... I DON¿T HAVE DATA ON THE EXACT CATHETER IN QUESTION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    969533 GBX COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other| R