MAUDE Adverse Event Report: COOK ENDOSCOPY FUSION LITHOTRIPSY EXTRACTION BASKET; FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL

Catalog Number FS-LXB-3X6

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/19/2018

Event Type  Injury  

Manufacturer Narrative

Additional concomitant medical products: boston scientific alliance handle, unknown model, medwork cable and handle, unknown model.Occupation: non-healthcare professional.Investigation evaluation: the product is being returned for evaluation and the investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report with product evaluation information.

Event Description

During a lithotripsy procedure, the physician used a cook fusion lithotripsy extraction basket.An extraction [of stones was attempted] with the basket.A distant learning [sic] was not possible without lithotripsy.The lithotripsy extraction basket handle [was loaded] into the alliance handle.A slow attempt to shred the stone [was made].The lithotripsy extraction basket was torn by the hand [handle].Emergency lithotripsy was not possible.Surgery was performed to remove the stones and the lithotripsy extraction basket.A section of the device did not remain inside the patient¿s body.The patient required surgery to remove the stones and basket due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Boston scientific alliance handle, unknown model.Medwork cable and handle, unknown model.Cook fusion omni-tome pre-loaded sphincterotome, fs-omni-35-260.Occupation: non-healthcare professional.Investigation evaluation: our evaluation of the product said to be involved confirmed the report.The orange wire guide lumen on the distal end of the device has been stripped along its full length.The catheter has kinks throughout the length.The wire basket appeared stretched and was returned separated from the drive wire, likely cut.The drive wire was returned separate from the catheter and not attached to the handle.It appears as if the drive wire broke near the handle.The drive wire was 183 cm in length.There was brown/red residue on the inside tip of the basket and along some parts of the drive wire.The handle advanced and retracted without resistance.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: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.The instructions for use (ifu) state the following warning: "basket wires may fragment and/or stone impaction may occur during lithotripsy, requiring surgical intervention." the ifu states the following: "caution: if difficulty is encountered when removing basket from duct, do not use excessive force." the ifu also states "damage to wire guide lumen may result if zip port is visible and device is pulled from accessory channel with wire guide locked in wire guide locking device." 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 review of the complaint history was conducted and this represents an unusual occurrence.The likelihood of occurrence is considered rare.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.

Event Description

During a lithotripsy procedure, the physician used a cook fusion lithotripsy extraction basket.An extraction [of stones was attempted] with the basket.A distant learning [sic] was not possible without lithotripsy.The lithotripsy extraction basket handle [was loaded] into the alliance handle.A slow attempt to shred the stone [was made].The lithotripsy extraction basket was torn by the hand [handle].Emergency lithotripsy was not possible.Surgery was performed to remove the stones and the lithotripsy extraction basket.A section of the device did not remain inside the patient¿s body.The patient required surgery to remove the stones and basket due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: FUSION LITHOTRIPSY EXTRACTION BASKET
• Type of Device: FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 8236278
• MDR Text Key: 132788364
• Report Number: 1037905-2019-00015
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002482784
• UDI-Public: (01)00827002482784(17)211022(10)W4134748
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2021
• Device Catalogue Number: FS-LXB-3X6
• Device Lot Number: W4134748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Date Manufacturer Received: 12/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS TJF-180 ENDOSCOPE.
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR