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

Catalog Number FS-LXB-3X6

Device Problems Difficult to Fold, Unfold or Collapse (1254); Nonstandard Device (1420); Material Separation (1562); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2022

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 ercp for common bile duct stone extraction, the physician used a cook fusion lithotripsy extraction basket.It was reported that the user captured the stone with basket, but discovered the basket wire broken during lithotripsy.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: the product said to be involved was returned in a white plastic bag with a box from the lot number provided in the report.The label matches the product returned.Photos provided show the device with the basket partially advanced with the handle in the fully retracted position and the product label.The lot number matches the report.Our evaluation of the product said to be involved confirmed the report.The device returned with the handle in the retracted position and the basket nearly fully advanced out of the sheath but not expanded.The device responded to manipulation of the handle and advanced appropriately.Dimensional verification confirmed the length between proximal end of the orange y-body to the distal end of the coil spring assembly is with specifications.The basket appears fully formed and intact with yellowish/ green substance on the wires.The basket cannot be fully retracted.Upon further evaluation the handle was disassembled.While the basket assembly was still in the cannula it was able to be removed with little resistance and under magnification there is minimal damage to the proximal end of the basket assembly from removal.There is evidence of weld at the proximal end of the cannula.A lab meeting was held on 15 nov 2022 with quality engineering, production leadership from the metals department, and manufacturing engineering.It was found that the device was manufactured to specification.Evidence of the torquing process on the cannula was verified.A detached portion of the drive wire remains attached to the weld in the proximal tip of the cannula indicating the weld was sufficient and the drive wire fracture occurred distal to it.This is consistent with breakage during lithotripsy.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.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 report of drive wire breakage indicative of breakage during lithotripsy.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

Investigation evaluation: the product said to be involved was returned in a white plastic bag with a box from the lot number provided in the report.The label matches the product returned.Photos provided show the device with the basket partially advanced with the handle in the fully retracted position and the product label.The lot number matches the report.Our evaluation of the product said to be involved confirmed the report.The device returned with the handle in the retracted position and the basket nearly fully advanced out of the sheath but not expanded.The device responded to manipulation of the handle and when advanced 5.3cm of the proximal basket assembly exited the sheath, measuring from the distal end of the coil spring assembly to the proximal end of the basket.Dimensional verification confirmed the length between proximal end of the orange y-body to the distal end of the coil spring assembly is with specifications.The basket appears fully formed and intact with yellowish/ green substance on the wires.The basket cannot be fully retracted.Upon further evaluation the handle was disassembled.While the basket assembly was still in the cannula it was able to be removed with little resistance and under magnification there is minimal damage to the proximal end of the basket assembly from removal.There is evidence of weld at the proximal end of the cannula.A lab meeting was held on 15 nov 2022 with quality engineering, production leadership from the metals department, and manufacturing engineering.The cover plate and t-nut were removed from the handle on the device.Evidence of the torquing process on the cannula was verified.A detached portion of the drive wire remains attached to the weld in the proximal tip of the cannula indicating the weld was sufficient and the drive wire fracture occurred distal to it.In response to an identified manufacturing issue the torque on the device was reassessed.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.While the weld was confirmed, the torque is the primary mode of securing the drive wire within the cannula.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 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: 15788586
• MDR Text Key: 305552300
• Report Number: 1037905-2022-00628
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FS-LXB-3X6
• Device Lot Number: W4589622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2022
• Date Manufacturer Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2022
• 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.
• Patient Age: 72 YR
• Patient Sex: Male