WILSON-COOK MEDICAL INC MEMORY II DOUBLE LUMEN EXTRACTION BASKET; FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL
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Catalog Number MB-35-2X4-8 |
Device Problems
Difficult to Fold, Unfold or Collapse (1254); Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/27/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation evaluation: the product said to be involved was returned in a clear bag.The lot number was not returned with the device.Our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the basket fully retracted and a clear liquid inside the tubing.The handle moved freely and when manipulated the basket would not move.The handle was disassembled and it was noted that the drive wire has separated from the handle with nested of the wire noted in the purple hub.For further evaluation of the drive wire cable and basket, the catheter was cut to push the drive wire cable out of the sheath.The basket was fully formed and intact, and evidence of solder was present on the handle cannula at the joint.No other anomalies were detected with the device.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusion the report of unable to open the basket was due to a separation of the device in the handle.The cause of the separation is unknown.The instructions for use indicates: "advance device through channel, in short increments, until basket sheath exits endoscope." the instructions for use also states: "confirm desired position of basket sheath relative to target.Advance basket out of sheath.Caution: pulling on sheath while advancing or retracting basket may damage device, rendering it inoperable." basket deployment difficulties and buckling/breaking of the drive wire can occur if the device experiences excessive pressure.Resistance in basket movement and bends in the catheter can occur if the elevator of the endoscope is used to deflect the device at a sharp angle.Prior to distribution, all memory ii double lumen extraction baskets are subjected to a visual inspection and functional testing to ensure device integrity.Corrective action corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
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Event Description
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During a procedure to remove a common bile duct stone, the physician used a memory ii double lumen extraction basket.It was reported that the basket (mb5-2x4-8) was opened to remove the cbd stone, but it did not open.There was no reportable information at this time.On 05/23/2022, the basket was returned for evaluation and found that the drive wire has separated from the handle with nested of the wire noted in the purple hub.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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Search Alerts/Recalls
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