MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC MEMORY EIGHT WIRE BASKET; BILIARY CATHETER AND ACCESSORIES

Model Number	G21538
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.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.Prior to distribution, all memory eight wire baskets are subjected to a visual inspection and functional testing to ensure device integrity.Corrective action: based on the quality engineering risk assessment no corrective action is warranted at this time.This observation occurred prior to use.A review of the complaint history was conducted.Based on this review, the likelihood of this type of report is rare.Quality assurance will continue to monitor for complaint trends.
Event or Problem Description
In preparation for cbd stone removal inside the biliary tract, the physician selected a cook memory ii double lumen extraction basket.It was reported that after removing the sleeve covering the basket and attempting to pull the handle to retract the basket into the sheath, the handle would not move.It could not be advanced or retracted.This occurred with four (4) devices from the same lot.This occurred prior to patient contact; there was no impact to the patient.
Additional Manufacturer Narrative
Investigation evaluation: the 4 devices said to be involved were returned in a clear plastic bag.Provided with the return was an open pouch from the lot number provided in the report.The label matches the products returned.Our evaluation of the product said to be involved confirmed the report.Device #1 was returned with the basket fully retracted.Evidence of the difficulty experienced by the user was noted as the handle cannula has bent and buckling of the clear catheter was noted distal to the white shrink tubing.The basket was advanced with slight resistance while in a relaxed, uncoiled, position on the table top.The basket appears fully formed and intact.When attempting retraction in the same position, notable resistance was encountered, but the basket was able to subsequently retract.Significant resistance experienced during initial retraction was found to decrease over the course of advancements and retractions.While coiled approximately 22 cm in diameter the basket was able to advance and retract with resistance.While coiled approximately 20 cm in diameter the basket was able to advance with significant of resistance and would not retract.When the catheter was fully straightened the basket is able to advance and retract with minimal resistance.Some friction was felt as the drive wire passed through the buckled portion of the clear tubing.Compression of the buckled clear tubing was noted during retraction.Device #2 was returned with the basket fully advanced.Evidence of the difficulty experienced by the user was noted as buckling of the clear catheter was noted distal to the white shrink tubing.The basket appears fully formed and intact.When attempting retraction while in a relaxed, uncoiled, position on the table top, significant resistance was encountered, the basket was able to subsequently retract.Resistance was also observed during basket advancement.The amount of resistance experienced did not improve over the course of advancements and retractions as with device #1.When the catheter was fully straightened the basket is able to advance and retract with minimal resistance.Some friction was felt as the drive wire passed through the buckled portion of the clear tubing.Compression of the buckled clear tubing was noted during retraction.Device #3 was returned with the basket fully advanced.No buckling of the clear catheter or kinking of the handle cannula was noted.The basket appears fully formed and intact.When attempting retraction while in a relaxed, uncoiled, position on the table top, the basket was unable to retract due to extreme resistance.When the catheter was fully straightened the basket is able to advance and retract without resistance.The amount of resistance experienced slightly improve over the course of advancements and retractions allowing for slight relaxation of the catheter to be tolerated during retraction.Device #4 was returned with the basket fully advanced.Evidence of the difficulty experienced by the user was noted as the handle cannula has bent and buckling of the clear catheter was noted distal to the white shrink tubing.The basket appears fully formed and intact.When attempting retraction while in a relaxed, uncoiled, position on the table top, significant resistance was encountered, the basket was able to subsequently retract.Resistance was also observed during basket advancement.The amount of resistance experienced did not improve over the course of advancements and retractions as with device #1.When the catheter was fully straightened the basket is able to advance and retract with minimal resistance.Some friction was felt as the drive wire passed through the buckled portion of the clear tubing.Compression of the buckled clear tubing was noted during retraction.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Investigation conclusion: our laboratory evaluation of the products said to be involved confirmed the report of difficulty advancing and/or retracting.The cause of the advancement and retraction difficulty is unknown.A corrective action (capa) has been initiated to address instances of difficulty during basket advancement and retraction.The product said to be involved is included in the scope of the corrective actions.Prior to distribution, all memory eight wire baskets are subjected to a visual inspection and functional testing to ensure device integrity.Corrective action: a corrective action (capa) has been initiated in an effort to reduce occurrences of this nature.The product said to be involved is included in the scope of the corrective action.A review of the complaint history was conducted.Quality assurance will continue to monitor for complaint trends.

• Brand Name: MEMORY EIGHT WIRE BASKET
• Common Device Name: BILIARY CATHETER AND ACCESSORIES
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston salem NC 27105
• Manufacturer (Section G): WILSON-COOK MEDICAL INC; 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: 23302741
• Report Number: 1037905-2025-00710
• Device Sequence Number: 14668460
• Product Code: LQR
• UDI-Device Identifier: 00827002215382
• UDI-Public: (01)00827002215382(17)280714(10)W4955162
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K171969
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G21538
• Device Catalogue Number: MB5-2X4-8
• Device Lot Number: W4955162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS TJF-260
• Patient Sex: Unknown