MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC FUSION WIRE GUIDED EXTRACTION BASKET; LQR DISLODGER, STONE, BILIARY

Catalog Number FS-XB-2X4

Device Problem Material Rupture (1546)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

During a biliary stone extraction, the physician used a cook fusion wire guided extraction basket.It was reported that the basket got stuck in the patient with a 1 cm stone in the basket.The sheath around the cable got stripped and so they had no control of the basket anymore and had to cut the handle off.The wires coiled up like a slinky but not as neat.They twisted on themselves.They attempted to use the soehendra lithotripter handle with the conquest ttc lithotripter cable and they were unable to feed the fusion basket cable into the conquest cable.They were unable to do it because of the level of deformity of the fusion cable.The patient had to be sent to the or for removal.

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.A review of the device history record could not be conducted because the lot number was not provided.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.To prevent damage to the device, the instructions for use states, "this device should never be coiled in less than an 8-inch (20 cm) diameter." basket deployment difficulties and buckling of the drive wire can occur if the device experiences excessive pressure.Resistance in basket extension and damage to the outer catheter can occur if the elevator of the endoscope is used to deflect the device at a sharp angle.Prior to distribution, all fusion wire guided 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.

• Brand Name: FUSION WIRE GUIDED EXTRACTION BASKET
• Type of Device: LQR DISLODGER, STONE, BILIARY
• 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: 18778836
• MDR Text Key: 336224343
• Report Number: 1037905-2024-00109
• Device Sequence Number: 1
• Product Code: LQR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K171969
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FS-XB-2X4
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: OLYMPUS 190 DUODENOSCOPE
• Patient Outcome(s): Hospitalization