MAUDE Adverse Event Report: COOK ENDOSCOPY MEMORY HARD WIRE BASKET; FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL

Model Number G22002

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

Continued from occupation: non-healthcare professional.Investigation evaluation: the photo provided by the user shows one of the wires on the basket broken loose from the proximal end of the basket.Our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the basket fully extended out of the catheter lumen.There was fluid in the catheter lumen.There were bends throughout the length of the catheter and the distal end of the catheter was damaged.The distal tip of the catheter lumen was intact, but appeared to be slightly crushed.There was an unknown substance on the drive wire of the basket.One of the wires on the basket had broken loose from the proximal end of the basket, just distal to the solder joint.The wire was still attached to the distal end of the basket.The basket wire was broken near the soldered joint; there was no evidence of the wire being damaged by the manufacturing process.Under magnification, it looked as if the wire may have been crushed, because there still was solder at the joint.The basket was intact and no part of the device was missing.No other anomalies were detected.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.The basket wire broke at the soldered joint.If excessive force is applied, basket breakage can occur at or near the soldered joint.Prior to distribution, all memory hard wire 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: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.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 hard wire basket.The user advanced the device to the desired position and [captured] a stone.Then the user pulled the device a little and observed that a basket wire had broken from the device body [during] endoscopy.The user withdrew the device from the endoscope immediately and confirmed there was no device part left in patient.The user then used another of the same device and finished the procedure.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 HARD WIRE 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: 8199682
• MDR Text Key: 132351890
• Report Number: 1037905-2018-00607
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002220027
• UDI-Public: (01)00827002220027(17)210807(10)W4101070
• Combination Product (y/n): N
• Reporter Country Code: CN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2021
• Device Model Number: G22002
• Device Catalogue Number: MWB-2X4
• Device Lot Number: W4101070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Date Manufacturer Received: 12/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 60