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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 07/09/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation evaluation: the product said to be involved was returned in an open pouch from the lot number provided in the report.The label matches the product returned.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 basket was function tested and when the handle was manipulated the basket did not move.The handle was disassembled and it was noted that the drive wire has disconnected from the handle with nesting of the wire 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 devices.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.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.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.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 an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook memory ii double lumen extraction basket it was initially reported that at the target site in the common bile duct, the basket would not open.The user [physician] replaced the device with another one to complete the procedure.The device was received for evaluation on 11-aug-2021.The basket was function tested and it was identified by the quality engineer that when the handle was manipulated the basket did not move.The handle was disassembled and it was noted that the drive wire has disconnected from the handle with nesting of the wire in the purple hub.[subject of report].A section of the device did not remain inside the patients¿ 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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