MAUDE Adverse Event Report: COOK ENDOSCOPY MEMORY II DOUBLE LUMEN EXTRACTION BASKET; FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL

Model Number G25149

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/07/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved determined that the drive wire was separated from the cable.The basket would not move when the handle was manipulated.The device was returned with the basket fully retracted and clear fluid present in the lumen.Although the handle could move during functional testing, the basket does not advance/retract with handle movement.There was a grinding sound/feeling with handle manipulation.The handle was disassembled and it was noted that the drive wire was separated from the cable.Nesting was noted inside the purple hub.The portion of drive wire cable remaining attached to the handle cannula had nested (bunched up against the handle cannula).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 is fully formed with a wire dislodged from the distal metal tip.The drive wire cable from inside the sheath has nested.Solder is present on the handle cannula and drive wire cable at the joint.No other anomalies were detected with the device.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: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.Basket advancement/retraction difficulties and nesting 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.The instructions for use indicate: "advance device through channel, in short increments, until basket sheath exits endoscope." the instructions for use state: "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." 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.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook memory ii double lumen extraction basket.The basket was retracted into the sheath after the physician removed the device from the packaging pouch prior to use.(he only retracted the basket into the sheath and did not verify the basket extension and retraction during preparation).The patient's anatomy was not tortuous, so the endoscope was positioned with no difficulty.The device was advanced through the bile duct, then the user attempted to open the basket.However, because the basket would not open, another mb-35-2x4-8 was used instead to complete the procedure.There have been no adverse effects to the patient reported.There was no reportable information at this time.The device was evaluated on 17-sep-2018 and it was determined that the drive cable was disconnected from the drive wire.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.

• Brand Name: MEMORY II DOUBLE LUMEN EXTRACTION BASKET
• Type of Device: FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 7958293
• MDR Text Key: 125440204
• Report Number: 1037905-2018-00477
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002251496
• UDI-Public: (01)00827002251496(17)210706(10)W4087044
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2021
• Device Model Number: G25149
• Device Catalogue Number: MB-35-2X4-8
• Device Lot Number: W4087044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2018
• 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