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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC MEMORY HARD WIRE BASKET FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL

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WILSON-COOK MEDICAL INC MEMORY HARD WIRE BASKET FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL Back to Search Results
Catalog Number MWB-2X4
Device Problems Difficult to Fold, Unfold or Collapse (1254); Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/25/2022
Event Type  malfunction  
Event Description
During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook memory hard wire basket. It was reported that this was the second ercp of the patient and the physician was catching the stone with the basket for first attempt and found out the handle detached. The physician retrieved the basket along with the stone captured from patient, then changed to another same device to complete 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.
 
Manufacturer Narrative
Investigation evaluation: a product evaluation was performed only by the pictures provided in response to this report because the product said to be involved was not provided to cook for evaluation. One picture shows the front of the marketing box, and the lot number matches the report. The two additional pictures show the device, the basket is advanced, and the handle has disconnected from the drive wire cable. 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 statements and photos 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: 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. The instructions for use 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 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.
 
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Brand NameMEMORY HARD WIRE BASKET
Type of DeviceFFL, 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 Key14205934
MDR Text Key290058088
Report Number1037905-2022-00194
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberMWB-2X4
Device Lot NumberW4498584
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received07/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/23/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/26/2022 Patient Sequence Number: 1
Treatment
ENDOSCOPE - UNKNOWN MAKE OR MODEL.
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