BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUANTUM TTC COLONIC BALLOON DILATOR

    MDR report key: 12023810 · Received June 18, 2021

    Report

    Report Number
    1037905-2021-00259
    Event Type
    Injury
    Date Received
    June 18, 2021
    Report Date
    August 17, 2021
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AJLOUNI, Y., ISER, J. H., & GIBSON, P. R. (2007). ENDOSCOPIC BALLOON DILATATION OF INTESTINAL STRICTURES IN CROHN'S DISEASE: SAFE ALTERNATIVE TO SURGERY. JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY, 22(4), 486¿490. HTTPS://DOI.ORG/10.1111/J.1440-1746.2006.04764.X. INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSION: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. HOWEVER A DEVICE FAILURE WAS NOT REPORTED IN THE ARTICLE. THE ARTICLE INDICATES THAT THE QDC WAS USED WITH ONE PATIENT THAT EXPERIENCED COMPLICATIONS. THE PATIENT WAS REPORTED TO HAVE AN ILEAL STRICTURE WITH OBSTRUCTIVE SYMPTOMS. THIS STRICTURE IS OUTSIDE THE INTENDED USE OF THE QDC DEVICE. THE INSTRUCTIONS FOR USE STATE "THIS DEVICE IS USED TO DILATE STRICTURES OF THE GASTROINTESTINAL TRACT, INCLUDING STRICTURES OF THE ESOPHAGUS, PYLORUS, DUODENUM, AND COLON." "DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN STATED INTENDED USE." THE INSTRUCTIONS FOR USE ALSO STATES THE AS POTENTIAL CONTRAINDICATIONS "THOSE ASSOCIATED WITH GASTROINTESTINAL ENDOSCOPY INCLUDE, BUT ARE NOT LIMITED TO: PERFORATION, HEMORRHAGE, ASPIRATION, FEVER, INFECTION, ALLERGIC REACTION TO MEDICATION, HYPOTENSION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST." PRIOR TO DISTRIBUTION, ALL QUANTUM TTC COLONIC BALLOON DILATORS ARE SUBJECTED TO A VISUAL EXAMINATION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED AND THIS REPRESENTS AN ISOLATED OCCURRENCE. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ON-GOING. A FOLLOW-UP EMDR WILL BE SENT FOLLOWING THE COMPLETING OF THE INVESTIGATION. AJLOUNI, Y., ISER, J. H., & GIBSON, P. R. (2007). ENDOSCOPIC BALLOON DILATATION OF INTESTINAL STRICTURES IN CROHN'S DISEASE: SAFE ALTERNATIVE TO SURGERY. JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY, 22(4), 486¿490. HTTPS://DOI.ORG/10.1111/J.1440-1746.2006.04764.X.

    Description of Event or Problem · 1

    COOK ENDOSCOPY WAS NOTIFIED OF THIS EVENT VIA A CLINICAL LITERATURE ARTICLE INVOLVING ONE (1) COOK QUANTUM TTC COLONIC BALLOON DILATOR. THIS ARTICLE WAS PUBLISHED IN 2017. PLEASE SEE BELOW FOR RELEVANT EXCERPTS OF THIS ARTICLE. ¿THIS STUDY AIMED TO DETERMINE THE OUTCOMES OF EBD [ENDOSCOPIC BALLOON DILATION] BY A SINGLE ENDOSCOPIST USING A DEFINED TECHNIQUE. PATIENTS WERE SELECTED ON THE BASIS OF THE DEMONSTRATION OF A STRICTURE AT COLONOSCOPY, PERFORMED UNDER ROUTINE SEDATION (MIDAZOLAM, FENTANYL AND PROPOFOL). IN ADDITION, HYOSCINE BUTYL BROMIDE WAS ALWAYS GIVEN TO OVERCOME ANY POSSIBLE INFLUENCE FROM SMOOTH MUSCLE SPASM. BARIUM DEFINITION OF THE PRESENCE OR LENGTH OF THE STRICTURE WAS NOT A PREREQUISITE. PATIENTS GAVE WRITTEN, INFORMED CONSENT THAT INCLUDED DILATATION OF A STRICTURE PRIOR TO THE COLONOSCOPY BEING PERFORMED. DILATATION WAS NOT ATTEMPTED WHEN THE ENDOSCOPIST ASSESSED THAT ACCESS TO THE STRICTURE WAS TOO DIFFICULT, WHEN MUCOSAL INFLAMMATION ASSOCIATED WITH THE STRICTURE WAS SEVERE, OR WHEN THERE WAS MARKED ULCERATION. A DECISION TO ATTEMPT DILATATION PROMPTED THE INTRAVENOUS ADMINISTRATION OF ANTIBIOTICS (USUALLY GENTAMICIN 80¿240 MG PLUS AMOXICILLIN 1 G, UNLESS SPECIFIC CONTRAINDICATIONS WERE PRESENT). EITHER A GUIDEWIRE OR BALLOON TIP WAS GENTLY PASSED THROUGH THE STRICTURE. IF ITS PASSAGE WAS NOT EASY, THE PROCEDURE WAS ABANDONED AND CONSIDERED A TECHNICAL FAILURE. THROUGH-ENDOSCOPIC BALLOONS (CRE; BOSTON SCIENTIFIC, CORK, IRELAND OR QUANTUM; COOK ENDOSCOPY,WINSTON-SALEM, NC, USA) WERE USED. THE INFLATION SITE AND PRESSURE DEPENDED ON THE INITIAL STRICTURE SIZE AND REACHED BETWEEN 15 AND 20 MM DIAMETER FOR UP TO 2 MIN. THE DILATATION WAS REPEATED ONCE OR TWICE, WHEN NECESSARY, AFTER THE PASSAGE OF THE ADULT COLONOSCOPE THROUGH THE STRICTURE WAS ATTEMPTED. IF THE STRICTURE WAS LONGER THAN THE INITIALLY DILATED SEGMENT, THE BALLOON WAS PROGRESSED AND FURTHER DILATATION(S) PERFORMED. ANTIBIOTICS (METRONIDAZOLE 400 MG TWO TO THREE TIMES DAILY WITH OR WITHOUT AMOXICILLIN 500 MG THREE TIMES DAILY) WERE CONTINUED ORALLY FOR 7 DAYS FOLLOWING THE PROCEDURE. THIRTY-SEVEN PATIENTS HAD EBD ATTEMPTED ON 83 STRICTURES. FIFTEEN PATIENTS WERE MEN. THEIR AGES RANGED FROM 22-75 YEARS WITH A MEDIAN OF 41 YEARS. THE INDICATION FOR ATTEMPTED DILATATION OF ONE OR MORE STRICTURES WAS OBSTRUCTIVE SYMPTOMS IN 35 PATIENTS AND INABILITY TO VIEW THE ENTIRE COLON IN TWO PATIENTS. BIOPSIES AND SUBSEQUENT CLINICAL COURSE EXCLUDED NEOPLASIA AS THE CAUSE FOR THE STRICTURES IN ALL. THE DILATATION WAS TOLERATED WELL BY ALL PATIENTS. THERE WERE NO EPISODES OF ABDOMINAL PAIN, FRANK PERFORATION OR HEMORRHAGE. ONLY ONE PATIENT EXPERIENCED A COMPLICATION LIKELY TO BE RELATED TO THE EBD. A (B)(6) YEAR-OLD MAN HAD AN ILEAL STRICTURE WITH OBSTRUCTIVE SYMPTOMS. SEVEN DAYS AFTER SUCCESSFUL DILATATION, HE PRESENTED WITH FEVER AND ABDOMINAL PAIN. INTERESTINGLY, HE HAD NOT ADHERED TO THE ROUTINE POST-EBD ORAL ANTIBIOTIC REGIMEN. HE WAS INITIALLY TREATED WITH ORAL CIPROFLOXACIN AND THE SYMPTOMS ABATED. HOWEVER, THEY RECURRED 5 WEEKS LATER, AND COMPUTED TOMOGRAPHY SCAN SHOWED A LIKELY MESENTERIC ABSCESS. AT LAPAROTOMY, A MESENTERIC ABSCESS AND MARKED THICKENING OF THE TERMINAL ILEUM WERE NOTED. THE ABSCESS WAS DRAINED AND ABNORMAL ILEUM RESECTED WITH AN ILEOCECAL ANASTOMOSIS PERFORMED. HE HAD AN UNEVENTFUL RECOVERY.¿ IT WAS NOT REPORTED WITHIN THE CLINICAL ARTICLE IF A SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. THE PATIENT REQUIRED A LAPAROTOMY, DRAINAGE PROCEDURE, ILEAL RESECTION, AND ANTIBIOTIC REGIMEN DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT EXPERIENCED A MESENTERIC ABSCESS AND INTRA-ABDOMINAL FISTULA PROBABLY RELATED TO THE DILATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925526 QUANTUM TTC COLONIC BALLOON DILATOR KNQ, DILATOR, ESOPHAGEAL KNQ COOK ENDOSCOPY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention COLONOSCOPE, UNKNOWN MAKE OR MODEL