MAUDE Adverse Event Report: COOK ENDOSCOPY MEMORY SOFT WIRE BASKET; FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL

Model Number G21562

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/07/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: cook conquest ttc lithotriptor cable, ttcl-10.Cook soehendra lithotriptor, slh-1.Occupation: non-healthcare professional.Investigation evaluation: our evaluation of the product said to be involved confirmed the report.A section of the distal end of the basket approximately 92 cm long was included in the return.The drive wire was broken and frayed at the proximal end of the returned portion of the device.The basket was misshapen.The basket tip was covered in a red/black substance and an orange substance.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 includes the following: "surgical intervention may be required if stone impaction and/or basket fragmentation occurs.If a stone cannot be removed endoscopically with this basket, the soehendra lithotriptor may be used with select memory soft wire baskets (see package label) to mechanically crush stone and aid in removal.Due to mechanical pressure generated with soehendra lithotriptor, basket fragmentation and/or stone impaction in common bile duct may occur and require surgical intervention.Risk of basket fragmentation or stone impaction must be weighed against potential benefit of using lithotriptor." prior to distribution, all memory soft wire 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.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 an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook memory soft wire basket.The user advanced the device through the duodenoscope to the desired position [common bile duct].The user caught the stone with the basket and was ready to do lithotripsy, when the inner wire of the basket broke at the distal end of the device.The user called the surgical team to carry out a surgical operation to remove the basket and stone from the patient.A section of the device did not remain inside the patient¿s body.The patient required surgery to remove the basket and stone due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence and is "doing well".

• Brand Name: MEMORY SOFT WIRE BASKET
• Type of Device: FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 8480349
• MDR Text Key: 140889031
• Report Number: 1037905-2019-00166
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00827002215627
• UDI-Public: (01)00827002215627(17)190518(10)W3722741
• Combination Product (y/n): N
• Reporter Country Code: CN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2019
• Device Model Number: G21562
• Device Catalogue Number: MSB-3X6
• Device Lot Number: W3722741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Date Manufacturer Received: 03/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 49