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

Catalog Number MB-35-2X4-8

Device Problems Fracture (1260); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant products: boston scientific jagwire 0.035 straight.Investigation evaluation: for device number 1, the device was returned with the basket fully retracted into the sheath.There was a liquid substance inside the tubing.During a functional test the handle was manipulated, and no movement was noted from the basket.The device was disassembled, and it was noted that the drive wire had disconnected from the handle.There was nesting of the wires inside the purple hub.For further evaluation of the drive wire cables and baskets, the catheter was cut to push the drive wire cable out of the sheath.The basket was fully formed with an unknown brown/red substance on the distal tip.The drive wire cable from inside the sheath has nested.Solder is present on the handle cannula at the joint.For device number 2, the device was returned with the basket fully retracted into the sheath.There was a liquid substance inside the tubing.During a functional test the handle was manipulated, and no movement was noted from the basket.The device was disassembled, and it was noted that the drive wire had disconnected from the handle.There was nesting of the wires inside the purple hub.For further evaluation of the drive wire cables and baskets, the catheter was cut to push the drive wire cable out of the sheath.The basket was fully formed.The drive wire cable from inside the sheath has nested.Solder is present on the handle cannula at the joint.No other anomalies were detected with the devices.A review of the device history record could not be conducted because the lot number was not provided.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.The instructions for use 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." the instructions for use also indicates: "advance device through channel, in short increments, until basket sheath exits endoscope." 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.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp), the nurse used cook memory ii double lumen extraction baskets.The extraction basket was inserted to the duct and the handle was pushed to capture the stone, however, the sheath would not move when the handle was pulled.After the stone was out of the duct, the extraction basket was removed out of the endoscope, gently.There was no reportable information at this time.On 10-feb-2020 the devices were returned and it was noted that the wires were disconnected from the handle with nesting in the purple hubs.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: 9797725
• MDR Text Key: 226588243
• Report Number: 1037905-2020-00125
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Reporter Country Code: KR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MB-35-2X4-8
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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