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

Model Number	00711652
Health Effect - Clinical Code	Perforation (2001)
Date of Event	02/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Through follow up with the user facility, us endoscopy learned that excessive force was applied in order to pass the sampling device through a hardened stricture.Statements in the instructions for use include: "when using a guide wire, hold the guidewire while brushing for cellular material.Otherwise the guidewire may move and cause patient injury.After selective cannulation of the desired duct is achieved and the guide wire is placed beyond the desired site for brushing: advance the infinity ercp sampling device over the guidewire.Observe the guidewire as it exits the hole approximately 20 cm from the tip of the catheter.If using a guidewire locking device, unlock the short guidewire per manufacturer's recommendations.Advance the device into the accessory channel of the endoscope and relock the guidewire.Using short strokes (1" - 1.5"), continue to advance the device until the distal end of the sheath is endoscopically visualized." the device subject of the reported event was not returned for evaluation.The device history record was reviewed and confirmed the device was manufactured to specification.There have been no other complaints associated with this lot.A us endoscopy representative has offered in-service training regarding use of the infinity ercp sampling device to the facility; however, the facility has declined.No additional issues have been reported.
Event or Problem Description
The user facility reported a perforation to the common bile duct during a sampling procedure which included use of the infinity ercp sampling device.A covered stent was placed to address the perforation and the patient is reported to have fully recovered.

• Brand Name: INFINITY ERCP SAMPLING DEVICE
• Common Device Name: SAMPLING DEVICE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 9831987
• Report Number: 1528319-2020-00008
• Device Sequence Number: 2204987
• Product Code: FDX
• UDI-Device Identifier: 00816765011782
• UDI-Public: (01)00816765011782
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K151889
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/13/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2021
• Device Model Number: 00711652
• Device Catalogue Number: 00711652
• Device Lot Number: 1818265
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 03/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1