BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NASAL PANCREATIC DRAINAGE SET

    MDR report key: 20253562 · Received September 19, 2024

    Report

    Report Number
    3001845648-2024-00514
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    June 12, 2019
    Report Date
    August 23, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K171623 INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K171623. DEVICE EVALUATION: 85X NPDS-7 DEVICES OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS COMPLAINT WAS RAISED FROM LITERATURE PAPER GUO 2019 AND WILL CAPTURE THE OFF LABEL USE OF NPDS DEVICE. THIS FILE IS RELATED TO (B)(4). LAB EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. DOCUMENT REVIEW: AS THE LOT NUMBER OF THE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL NPDS-7 DEVICES ARE SUBJECT TO VISUAL A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. HISTORICAL DATA NOT REVIEWED AS LOT NUMBER IS UNKNOWN. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0107) STATES THE FOLLOWING: ¿THE NASAL PANCREATIC DRAINAGE SET IS INTENDED FOR TEMPORARY ENDOSCOPIC DRAINAGE OF THE PANCREATIC DUCT THROUGH THE NASAL PASSAGE BY USE OF AN INDWELLING CATHETER¿. THE USER IS INSTRUCTED, DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN STATED INTENDED USE. THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU AS THE DEVICES WERE USED FOR POSTOPERATIVE WASHING OF THE CYST CAVITY, WHICH WAS AN OFF-LABEL USE. AS PER THE IFU, THIS DEVICE IS INTENDED FOR TEMPORARY ENDOSCOPIC DRAINAGE OF THE BILIARY DUCT. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. CONFIRMATION OF COMPLAINT: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF OFF LABEL USE WAS IDENTIFIED FROM THE AVAILABLE INFORMATION. THE DEVICES WERE USED FOR POSTOPERATIVE WASHING OF THE CYST CAVITY THIS IS OUTSIDE THE INTENDED USE OF THE DEVICE AS PER THE IFU NASAL PANCREATIC DRAINAGE SETS ARE INTENDED FOR TEMPORARY ENDOSCOPIC DRAINAGE OF THE PANCREATIC DUCT THROUGH NASAL PASSAGE BY USE OF AN INDWELLING CATHETER. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. AS PER THE IFU, THE USER IS INSTRUCTED NOT TO USE THE DEVICE FOR ANYTHING OTHER THAN THE INTENDED USE. CLINICAL INPUT CONFIRMED THE OFF-LABEL USE OF THE DEVICE. SUMMARY: FAILURE IDENTIFIED: OFF LABEL USE - 85 DEVICES CONFIRMED USED. A DEFINITIVE ROOT CAUSE OF OFF LABEL USE WAS IDENTIFIED FROM THE AVAILABLE INFORMATION. THE DEVICES WERE USED FOR POSTOPERATIVE WASHING OF THE CYST CAVITY THIS IS OUTSIDE THE INTENDED USE OF THE DEVICE AS PER THE IFU NASAL PANCREATIC DRAINAGE SETS ARE INTENDED FOR TEMPORARY ENDOSCOPIC DRAINAGE OF THE PANCREATIC DUCT THROUGH NASAL PASSAGE BY USE OF AN INDWELLING CATHETER. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. AS PER THE IFU, THE USER IS INSTRUCTED NOT TO USE THE DEVICE FOR ANYTHING OTHER THAN THE INTENDED USE. CLINICAL INPUT CONFIRMED THE OFF-LABEL USE OF THE DEVICE. THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENTS DID NOT EXPERIENCE ANY HEALTH CONSEQUENCES OR ADVERSE EFFECTS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS.

    Description of Event or Problem · 0

    GUO, 2019 ¿ MULTIVARIATE ANALYSIS OF THE FACTORS AFFECTING THE PROGNOSIS OF WALLED-OFF PANCREATIC NECROSIS AFTER ENDOSCOPIC ULTRASOUND-GUIDED DRAINAGE PLASTIC STENTS WERE USED IN 61 PATIENTS (71.8%), OF WHOM 14 RECEIVED 2 OR MORE STENTS. EUS-GUIDED DRAINAGE WITH PLASTIC STENTS FOR PLASTIC STENT DELIVERY, A 19-G NEEDLE (EUS N-19-T; WILSON-COOK MEDICAL, WINSTON-SALEM, NC) WAS USED FOR PUNCTURE. AFTER WITHDRAWING THE INNER NEEDLE STYLET, SOME FLUID WAS ASPIRATED FOR ROUTINE CYTOLOGICAL, BIOCHEMICAL, AND MICROBIOLOGICAL ANALYSIS AND CULTURE. A 0.035-INCH GUIDEWIRE (JAGWIRE; BOSTON-SCIENTIFIC, NATICK, MA) WAS INSERTED THROUGH THE NEEDLE LUMEN INTO THE CYST. SUBSEQUENTLY, A CYSTOTOME (10 FR; WILSON-COOK MEDICAL) WAS USED TO DILATE THE TRACT AND CREATE A LARGE FISTULA. AN EXPANDING BALLOON CATHETER (8¿10 MM IN DIAMETER) WAS OCCASIONALLY USED TO EXPAND THE FISTULA. WE INSERTED 1¿3 DOUBLE-PIGTAIL (DP) PLASTIC STENTS, 7¿10 FR IN DIAMETER AND 3¿9 CM IN LENGTH (7, 8.5 OR 10 FR; ENDO-FLEX GMBH, VOERDE, GERMANY), ALONG THE GUIDEWIRE. IN SOME PATIENTS, A NASOCYSTIC DRAINAGE TUBE (7 FR; WILSON-COOK MEDICAL) WAS USED FOR POSTOPERATIVE WASHING OF THE CYST CAVITY. METAL STENT WAS USED IN 24 PATIENTS (28.2%), INCLUDING DOUBLE-FLARED STENTS IN 18, STRAIGHT STENTS IN 3, AND DOUBLE-FLARED STENTS WITH PLASTIC STENTS IN 3. EUS-GUIDED DRAINAGE WITH METAL STENTS FOR METAL STENT DELIVERY, A 19-G NEEDLE (EUS N-19-T; WILSON-COOK MEDICAL) WAS USED FOR PUNCTURE, A SMALL AMOUNT OF CYST FLUID WAS WITHDRAWN FOR EXAMINATION, AND AN INDWELLING GUIDEWIRE WAS PLACED. A 10-FR CYSTOTOME (WILSON-COOK MEDICAL) WAS INSERTED ALONG THE GUIDEWIRE, A STOMACH/DUODENUM-CYST FISTULA WAS CREATED, AND A METAL STENT (10¿16 MM IN DIAMETER) WAS INTRODUCED OVER THE GUIDEWIRE, WHICH INCLUDED A FULLY COVERED SELF-EXPANDING METAL STENT (BOSTON-SCIENTIFIC, NATICK, MA) OR A LUMEN-APPOSING COVERED SELF-EXPANDING METAL STENT (10 MM IN DIAMETER; MICRO TECHNIQUE, NANJING, CHINA). EUS-GUIDED DRAINAGE WITH A DOUBLE-FANGED FULLY COVERED METAL STENT WITH ELECTROCAUTERY. BEFORE THE DELIVERY OF A DOUBLE-FANGED FULLY COVERED METAL STENT WITH ELECTROCAUTERY (10 MM IN DIAMETER; MICRO TECHNIQUE, NANJING, CHINA), A LINEAR ARRAY ECHOENDOSCOPE WAS USED TO EXAMINE THE WOPN. THE COLOR DOPPLER FUNCTION WAS UTILIZED TO DETERMINE WHETHER THE PUNCTURE SITE CONTAINED BLOOD VESSELS. A DOUBLE-FANGED FULLY COVERED METAL STENT WITH ELECTROCAUTERY WAS USED TO CONSTRUCT A FISTULA AND INSERT THE STENT. A NASOCYSTIC DRAINAGE TUBE (7 FR; WILSON-COOK MEDICAL) WAS SOMETIMES USED FOR PFC CAVITY LAVAGE. THIS COMPLAINT WAS OPENED TO CAPTURE 85 PATIENTS WHO EXPERIENCED OFF LABEL USE WITH A NPDS-7. PATIENT OUTCOME: NO INFORMATION PATIENT/EVENT INFO - NOTES: A TOTAL OF 85 PATIENTS (MALE/FEMALE, 50/35).

    Description of Event or Problem · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 23 AUG 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2533048 NASAL PANCREATIC DRAINAGE SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male