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

Model Number 00711652

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 02/13/2020

Event Type  Injury  

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 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
• Type of Device: SAMPLING DEVICE
• 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 rd; mentor, OH 44060 ; 4403586251
• MDR Report Key: 9831987
• MDR Text Key: 183479508
• Report Number: 1528319-2020-00008
• Device Sequence Number: 1
• Product Code: FDX
• UDI-Device Identifier: 00816765011782
• UDI-Public: (01)00816765011782
• 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: Other
• Type of Report: Initial
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 02/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2018
• 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