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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 Consequences Or Impact To Patient (2199)
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Event Date 06/05/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report and determined that the drive wire separated from the handle.The device was returned with water inside of the tubing and the basket fully retracted.During a function test it was noted that the basket would not move when the handle was manipulated.The handle was taken apart and it was noted that the drive wire had separated from the handle with nesting inside of 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.An unknown yellow substance was observed on the distal tip of the basket.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 procedure, the physician used a memory ii double lumen extraction basket in the bile duct, but the user confirmed that the basket would not open when he was testing the device function prior to patient contact.Therefore, another manufacturer's device was used instead to continue the procedure.There have been no adverse effects to the patient reported.Additional information was received on (b)(6) 2020 which stated that the event occurred not prior to use but during the procedure.The basket was used in the common bile duct to remove biliary sludge, but the basket did not open in the bile duct during the first attempt.Therefore, another manufacturer's device was used instead to complete the procedure.There have been no adverse effects to the patient reported.The device was received for evaluation on 7 july 2020 where it was determined that the drive wire had detached from the handle [subject of report].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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