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 Problems Foreign Body In Patient (2687); Gastrointestinal Hemorrhage (4476)

Event Date 01/31/2024

Event Type  malfunction  

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 cook rep was contacted and suggested that they remove the scope, recannulate, and try to use another device to push the stone out of the basket and pull the basket out.They were able to employ the technique recommended by the cook rep with another basket and avoid surgery.The procedure took 1.5 hours longer than usual.They were able remove the basket and crushed up stone with another fusion lithotripsy basket.A section of the device did not remain in the patient's body.There was a delay in procedure and minor bleeding due to extra manipulation.

Manufacturer Narrative

This investigation is ongoing.A follow-up report will be submitted with 30 days of submission of this report.

Manufacturer Narrative

Investigation evaluation: the product said to be involved was returned in a yellow biohazard bag, provided with the return was an open pouch from the lot number provided in the report.The label matches the product returned.Our evaluation of the product said to be involved confirmed the report based on the state of the returned device.The device was returned in 3 segments, the basket was not included in the return.The first segment contains the device handle and the handle cannula.The handle is able to manipulate smoothly.The closer at the proximal end of the handle had been loosened allowing the handle pin-vise to release the drive wire assembly.The second segment contains the proximal end of the drive wire assembly, the cable cannula and a portion of the drive wire.The drive wire has been cut 51.6cm from the distal end of the cable cannula.The remaining portion of the drive wire remains firmly attached to the cable cannula.The final section contains the sheath tubing, shrink tubing and proximal wire port.The catheter tubing has torn at the proximal end from the distal end of the purple shrink tube to 155.5cm distal to it, this is likely where the drive wire ruptured through the sheath resulting in loss of control of the basket.The catheter has bends and deformation throughout.Additionally the tip of the catheter at the proximal end has split.Brown and black substances were noted within the catheter along it's length.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 product said to be involved confirmed the report.The condition of the returned device supports that the drive wire had ruptured through the sheath at the proximal end and reflects the reported difficulty experienced by the user.However, as not all components were returned, and due to device damage sustained during the procedure, 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.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.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.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: 18778796
• MDR Text Key: 337438361
• Report Number: 1037905-2024-00108
• 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,Followup
• Report Date: 03/19/2024

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FS-XB-2X4
• Device Lot Number: W4719729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2023
• 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 Sex: Male