MAUDE Adverse Event Report: GYRUS ACMI, INC FLEX-CATCH 4 WIRE NITINOL BASKET; EXTRACTOR, STONE REMOVAL

Model Number NT4F19115

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2019

Event Type  malfunction  

Manufacturer Narrative

The referenced device will not be returned as the user facility discarded the device following the procedure.Therefore, the exact cause of the reported event cannot be determined.As a preventive measure, the instruction manual provides warning that indicates, "certain objects may be too large to remove endoscopically with this retrieval device.To avoid complications fluoroscopic x-ray or some means of identification of an objects size should be used prior to attempting to remove.Do not use this device if the object is too large to be removed and/ or cannot be securely held in the stone dislodger.".

Event Description

The manufacturer was informed that during a urology procedure with stone retrieval, "when a stone was being quarried using the device, incarceration occurred on the way to the bladder".It was reported that the scope and the handle of the device was disassembled and only the endoscope was withdrawn out of the patient's body.Subsequently, a rigid endoscope was inserted into the patient, the stone in the basket wire of the device was crushed using a laser and the basket and inner shaft portion of the device were removed from the patient's body.The intended procedure was completed.There was no patient injury reported.The user facility discarded the device following the procedure.

Manufacturer Narrative

The oem (ep flex) performed a device history record (dhr) review and noted that the product was made according to valid specifications.There were no anomalies in the process or documentation.Since there were no anomalies found during the dhr review and the device was discarded by the user facility, the oem could not confirm/determine a root cause.

• Brand Name: FLEX-CATCH 4 WIRE NITINOL BASKET
• Type of Device: EXTRACTOR, STONE REMOVAL
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 9507411
• MDR Text Key: 204566113
• Report Number: 2951238-2019-01230
• Device Sequence Number: 1
• Product Code: FGO
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT-FGO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NT4F19115
• Device Lot Number: 91902073
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1