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

Model Number 00711652

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

On (b)(6) 2014, a us endoscopy product specialist received a complaint from customer (nurse manager, (b)(6)), concerning a physician's discontinued use of the infinity sampling device (00711652).The nurse manager conveyed the physician had stopped using the device because it may have led to pancreatitis in one of his patients, after endoscopic retrograde cholangiopancreatography (ercp).The device lot number and the date of the event were unknown.In follow up communication, the patient condition was described as a mild case of pancreatitis.The physician described a very tight stricture and stated he probably shouldn't have used the brush in that particular case.He stated that he will continue to use it in other cases.The physician did not report any device malfunction when operating the device.

Manufacturer Narrative

The device was not returned for evaluation.Consequently, there is no further investigation into the condition of the device.Post-ercp pancreatitis is a known complication of ercp.It can be triggered by multiple causative factors, including the mechanical, thermal, chemical and hydrostatic factors which are common to ercp.Clinical literature identifies pancreatitis is the most frequent complication of ercp (reference f.Donnellan and m.Byrne, "prevention of post-ercp pancreatitis." gastroenterology research and practice, vol.2012, article id 796751).The instructions for use (ifu) includes: contraindications include those specific to any endoscopic procedure, as well as those specific to ercp, and any techniques associated with ductal brush cytology.A review of complaint history (2011 - current) finds no other complaints reported for post-ercp pancreatitis with use of the infinity sampling device.Approximately (b)(4) devices were distributed during that same period.

• Brand Name: INFINITY SAMPLE DEVICE
• Type of Device: INFINITY SAMPLING DEVICE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: michael oleksa ; 5976 heisley road; mentor, OH 44060 ; 4403586263
• MDR Report Key: 3934655
• MDR Text Key: 17263974
• Report Number: 1528319-2014-00008
• Device Sequence Number: 1
• Product Code: FDX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/24/2014

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: Health Professional
• Device Model Number: 00711652
• Device Catalogue Number: 00711652
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/03/2014
• Initial Date FDA Received: 06/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other