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

Model Number 00711652

Device Problem Material Separation (1562)

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

Event Date 11/22/2019

Event Type  malfunction  

Manufacturer Narrative

The fluoroscopic marker is a radiopaque band situated within the guidewire lumen near the distal end of the device.The subject device has been returned to steris endoscopy.Evaluation of the returned device found a cut at the distal end of the catheter indicative of excessive lateral force between the guidewire and the catheter.Damage of this nature may compromise the marker bond to the catheter.The infinity sampling device is intended for use with a user-supplied 0.89mm guidewire.The user facility did not provide steris endoscopy with information regarding the guidewire used in this procedure.The instructions for use include the following statements: "when using a guidewire, irrigate the guidewire lumen of the catheter with sterile water/saline.Do not force the brush through the endoscope's channel.Reduce angulation of the scope if resistance is met.Prior to the procedure, actuate the handle several times to be sure the brush functions properly.If the unit does not function properly, or there is evidence of damage (e.G., bent brush, bent brush stem, kinked catheter), do not use this product and contact your local product specialist." the device history record was reviewed and confirmed the devices were manufactured to specification.There have been no other complaints associated with this lot.Steris endoscopy has offered in-service training on the use of the device; however, the user facility did not accept.There have been no further issues reported.

Event Description

The user facility reported that during a sampling procedure fluoroscopic marker from the infinity sampling device detached inside the patient.The detached portion of the device was retrieved with a snare.

• 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: 9492264
• MDR Text Key: 194472326
• Report Number: 1528319-2019-00046
• 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: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/04/2022
• Device Model Number: 00711652
• Device Catalogue Number: 00711652
• Device Lot Number: 1910005
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2019
• 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