MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. INFINITY ERCP SAMPLING DEVICE; CYTOLOGY BRUSH

Model Number 00711652

Device Problem Detachment Of Device Component (1104)

Patient Problems Complaint, Ill-Defined (2331); Foreign Body In Patient (2687)

Event Date 05/17/2016

Event Type  Injury  

Manufacturer Narrative

The disposable infinity ercp sampling device is intended to be used to retrieve cytological cell samples in the gastrointestinal tract.The user reported a portion of the infinity ercp device became detached during use.The device was used in a procedure which included placement of an ercp stent, with no report of complication.Two weeks following the procedure, the patient returned with recurrent symptoms of pancreatitis and x-ray found the infinity device brush head had been retained in the common bile duct.The brush head was removed from the patient in a subsequent procedure, and the patient is reported to be stable and fine.The device was not returned to us endoscopy for evaluation.Review of the manufacturing record (dhr) found all in-process and final inspections were performed and acceptable results documented.Information in the instructions for use (ifu) includes, "do not force the brush through the endoscope's channel.Reduce angulation of the scope if resistance is met." the report will be updated if additional information becomes available.Device not returned to manufacturer.

Event Description

The disposable infinity ercp sampling device is intended to be used to retrieve cytological cell samples in the gastrointestinal tract.The user reported a portion of the infinity ercp device became detached during use.The device was used in a procedure which included placement of an ercp stent, with no report of complication.Two weeks following the procedure, the patient returned with recurrent symptoms of pancreatitis and x-ray found the infinity device brush head had been retained in the common bile duct.The brush head was removed from the patient in a subsequent procedure, and the patient is reported to be stable and fine.

• Brand Name: INFINITY ERCP SAMPLING DEVICE
• Type of Device: CYTOLOGY BRUSH
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 5784185
• MDR Text Key: 49234689
• Report Number: 1528319-2016-00018
• Device Sequence Number: 1
• Product Code: FDX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151889
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/11/2016

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?: Yes
• Device Operator: Nurse
• Device Expiration Date: 08/31/2017
• Device Model Number: 00711652
• Device Catalogue Number: 00711652
• Device Lot Number: 1416741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2016
• Initial Date FDA Received: 07/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention