MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC THE WEB EXTRACTION BASKET; FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL

Catalog Number WEB-3X6

Device Problem Difficult to Fold, Unfold or Collapse (1254)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2024

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: a product evaluation was performed only by the picture provided in response to this report because the product said to be involved was not provided to cook for evaluation.The photo shows the product in a clear plastic bag, the basket assembly has been removed from the handle and sheath and the basket appears misshapen.Per the photo provided we cannot complete a full evaluation.Without the product or substantial evidence to contradict the complaint, it is considered confirmed based solely on the statements and photo describing the event.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: our evaluation of the photo provided confirmed the report.However, we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.Prior to distribution, all web 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: a review of the complaint history was conducted and this represents an unusual occurrence.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 unspecified extraction procedure, the physician used a cook web extraction basket.It was reported that the function was normal when tested prior to patient contact.When the basket reached the target and he want to retrieve the basket, it could not be folded.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.

Manufacturer Narrative

Investigation evaluation: the product said to be involved was returned in a clear plastic bag.A lot number was not provided with the returned device.The photo shows the product in a clear plastic bag, the basket assembly has been removed from the handle and clear catheter and the basket appears misshapen.Our evaluation of the product said to be involved confirmed the report based on the condition of the returned device.The product returned in three sections: the handle with the catheter cut distal to the white shrink tubing, the clear catheter, and the basket assembly.The clear catheter and drive wire have been cut distal to the white shrink tube leaving a small section of drive wire still attached to the handle.The portion of drive wire attached to the handle responds to handle manipulation without resistance in the handle.The cut catheter measured within specifications.Some slight deformation was observed at the distal end of the clear catheter.The basket is deformed and a white substance was observed on the basket wires.The basket assembly drive wire has been cut cleanly at the proximal end which supports the claim of difficulty to retract and likely indicates the user transitioned to lithotripsy, a product discrepancy or anomaly that could have contributed to this reported occurrence was not observed.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: our evaluation of the photo provided and the returned device confirmed the report.However, a definitive cause for the reported observation could not be determined because the condition of the product said to be involved prohibited a complete evaluation.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.Prior to distribution, all web 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: a review of the complaint history was conducted and this represents an unusual occurrence.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 unspecified extraction procedure, the physician used a cook web extraction basket.It was reported that the function was normal when tested prior to patient contact.When the basket reached the target and he want to retrieve the basket, it could not be folded.Additional information was received on 03 mar 2024 indicating that lithotripsy had been performed during 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: THE WEB EXTRACTION BASKET
• Type of Device: FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 18797485
• MDR Text Key: 337186356
• Report Number: 1037905-2024-00116
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: WEB-3X6
• Device Lot Number: W4601587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2022
• 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
• Treatment: LITHOTRIPSY CABLE TTCL-1; LITHOTRIPSY DEVICE SLC-2-D; SCOPE, UNKNOWN MAKE AND MODEL; SCOPE, UNKNOWN MAKE OR MODEL
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 76 KG