MAUDE Adverse Event Report: WILSON-COOK MEDICAL ACROBAT; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Catalog Number ACRO-35-450

Device Problems Peeled/Delaminated (1454); Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/14/2015

Event Type  malfunction  

Event Description

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.".

• Brand Name: ACROBAT
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): WILSON-COOK MEDICAL; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 5384982
• MDR Text Key: 36607498
• Report Number: 5384982
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/01/2018
• Device Catalogue Number: ACRO-35-450
• Device Lot Number: W3547317
• Other Device ID Number: G34266
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/04/2015
• Event Location: Hospital
• Date Report to Manufacturer: 12/04/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 77