FDA Adverse Event Malfunction Summary report: N

ACROBAT

MDR report key: 5384982 · Received January 22, 2016

Report

Report Number
5384982
Event Type
Malfunction
Date Received
January 22, 2016
Date of Event
November 14, 2015
Report Date
December 4, 2015
Manufacturer
WILSON-COOK MEDICAL
Product Code
OCY
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
FL, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE MD SWITCHED THE GUIDE WIRE FROM OLYMPUS VISIGLIDE TO THE COOK ACROBAT TO ASSIST IN GAINING ACCESS TO THE BILIARY DUCT. DURING PASSAGE OF THE ACROBAT INTO THE TOME, THE ACROBAT WIRE WOULD NOT PASS THROUGH. THE MD THEN WENT BACK TO THE VISIGLIDE WHICH PASSED THROUGH THE TOME WITHOUT DIFFICULTY. IN EXAMINING THE ACROBAT WIRE AFTER THE PROCEDURE, IT WAS FOUND THAT THE TEFLON COATING WAS STRIPPED. THERE WAS NO PATIENT IMPACT FROM THIS. MD NOTES FROM ERCP: "THE ERCP WAS TECHNICALLY DIFFICULT AND COMPLEX DUE TO CHALLENGING CANNULATION BECAUSE OF ABNORMAL ANATOMY. SUCCESSFUL COMPLETION OF THE PROCEDURE WAS AIDED BY PERFORMING THE MANEUVERS DOCUMENTED IN THIS REPORT. THE PROCEDURE WAS DETERMINED TO BE ASGE COMPLEXITY LEVEL3. FINDINGS: THE SCOUT FILM WAS NORMAL. THE ESOPHAGUS WAS SUCCESSFULLY INTUBATED UNDER DIRECT VISION. EXAMINATION OF THE PHARYNX, LARYNX AND ASSOCIATED STRUCTURES WAS NORMAL. THE SCOPE WAS PASSED UNDER DIRECT VISION THROUGH THE UPPER GI TRACT. THE UPPER GI TRACT WAS NORMAL. A LARGE-MOUTHED DIVERTICULUM WAS FOUND IN THE AREA OF THE PAPILLA. THE MAJOR PAPILLA WAS LOCATED ENTIRELY WITHIN A DIVERTICULUM. THE MAJOR PAPILLA WAS BULGING. THE MINOR PAPILLA WAS NORMAL. THE BILE DUCT COULD NOT BE CANNULATED WITH THE DASH SPHINCTEROTOME THAT WAS 0.035 INCHES. DEEP CANNULATION AND INJECTION OF CONTRAST INTO THE DORSAL PANCREATIC DUCT WAS ACCOMPLISHED WITH THE HYDRATOME AND GLIDEWIRE."

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
45476 ACROBAT ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY OCY WILSON-COOK MEDICAL W3547317

Patients

Seq Age Sex Outcome Treatment
1 74 YR