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

Catalog Number FS-LXB-2X4

Device Problems Nonstandard Device (1420); Material Split, Cut or Torn (4008)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/31/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.A follow-up emdr will be provided within 30 days of submission of this report.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook fusion lithotripsy extraction basket.It was reported that the physician attempted to use the basket over a wire inside of the patient's duct.When going to close the basket the middle of the device (catheter) snapped / broke.A section of the device did not remain inside the patient¿s body.The doctor was able to pass a balloon to stretch the papilla and pull out the basket.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 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.The investigation was limited to the information provided by the user.Several contributing factors were identified.In the responses provided it is stated that difficulty was encountered while attempting to manually fracture the stone due to the user being unfamiliar with the device.The instructions for use note "use of this device restricted to a trained healthcare professional".In addition, the information indicated that the sheath may not have been in place/secured during lithotripsy and a soehendra lithotripsy cable was used.This device is not compatible with the soehendra lithotripsy cable.The instructions for use contains the following warning "if a stone cannot be removed endoscopically with this basket, a compatible inflation/lithotriptor device and/or the conquest ttc lithotriptor cable with soehendra lithotriptor handle are needed to mechanically crush stone and aid in removal".The soehendra lithotripsy cable instructions for use contains the following warning "only select cook biliary soft wire baskets are recommended for use with this device.Do not remove the sheath from the basket wire.Doing so may result in basket fragmentation and consequently require surgical intervention" mechanical lithotripsy applies a high force to the basket wires and the stone.If the stone requires a force to fracture that exceeds the tensile strength of the basket wires, breakage will occur.The ifu includes the following warning "basket wires may fragment and/or stone impaction may occur during lithotripsy, requiring surgical intervention." prior to distribution, all fusion lithotripsy 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.

Manufacturer Narrative

The investigation is ongoing.A follow-up mdr will be submitted within 30 days of submission of this report.

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.Our laboratory evaluation of the product said to be involved confirmed the report.The device returned with the basket assembly fully removed from the sheath.A reddish-brown substance was noted at the baskets distal tip.The basket portion of the assembly is damaged/misshapen.The basket assembly had detached at the proximal end of the drive wire with slight damage sustained to the proximal end of the wires under magnification.There is evidence of weld at the proximal end of the cannula.During further evaluation the cover plate and t-nut were removed from the handle to evaluate if the cannula had been torqued properly.Upon visual inspection the deformation on the cannula, while present, was not sufficient when compared to a "known" good part.This indicates insufficient force applied during the torquing process.This is a likely cause for the drive wire detachment and the device is therefore, considered nonconforming.To further investigate, finished device manufactured by the same operator using the same equipment was pulled from the shelf stock and tested to determine if the tensile force was within specification.The testing showed 10 out of 13 devices did not meet the requirement minimum tensile value.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 returned device confirmed the cannula and drive wire was insufficiently torqued during the manufacturing process, leading to drive wire detachment.Production management and the department team leads were notified of this occurrence.A notification of operator related complaint form was provided to production management to make them aware of an operator related complaint and an operator retraining has been completed.Additionally, a capa has been initiated in an effort to reduce drive wire detachment during lithotripsy.Prior to distribution, all fusion lithotripsy 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 corrective action has been initiated in an effort to reduce occurrences of this nature.This product is included in the scope of this corrective action.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 LITHOTRIPSY 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: 16426329
• MDR Text Key: 310254050
• Report Number: 1037905-2023-00089
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002482774
• UDI-Public: (01)10827002482774(17)251129(10)W4660182
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FS-LXB-2X4
• Device Lot Number: W4660182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2022
• 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: SCOPE UNKNOWN MAKE AND MODEL