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

Catalog Number WEB-3X6

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 04/29/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation: non-healthcare professional.Concomitant medical products: cook soehendra lithotriptor handle, slh-1.Cook soehendra lithotripsy cable, slc-2.Investigation evaluation: a product evaluation was performed only by the pictures provided in response to this report because the product said to be involved was not provided to cook for evaluation.Per the photos provided we cannot complete a full evaluation.Without the product or substantial evidence to contradict the complaint, it is considered confirmed based solely on statements and photos describing the event.The lot number provided in the photos matches this report.The label in the photo matches the product reported.One of the pictures provided shows the device after use and surgical removal in addition to the device packaging.The photo shows all portions of the device except the catheter/sheath, the basket connected to the drive wire cable, a portion of the drive wire cable that appears to be the portion that was attached to the lithotripsy handle and the basket handle.The basket wires are deformed but still attached at the base and attached to the drive wire cable.The photo shows the handle and a small portion of drive wire cable where it was cut for lithotripsy.There is a break in the drive wire cable; we were unable to determine the location of the break.The catheter is not present on any portion of the drive wire cable.A scan of the device label is also provided.The other image provided shows a fluoroscopic image of the device in the patient.The drive wire cable appears mangled and disconnected from the device handle.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.Evaluation conclusion: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.The instructions for use for this device includes the following: "surgical intervention may be required if impaction occurs." the instructions for use of the sohendra lithotriptor handle warns, "due to the varying compositions of biliary stones, stone fracture may not be possible.If the stone cannot be fractured, continued rotation of the handle may cause the basket wire to break, requiring surgical intervention." prior to distribution, all web 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.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 emergent endoscopic retrograde cholangiopancreatography (ercp) with planned lithotripsy for acute cholangitis due to the stent having moved proximally to the stone and removal of a large gallstone in the common hepatic duct, the physician used a web extraction basket to extract the large gallstone.The basket wire broke and it was not possible to retrieve the basket, which remained stuck in the bile duct around the stone.A 12 cm plastic stent was placed proximally to the gallstone to drain the biliary ducts.The patient required surgery including adhesiolysis (removal of adhesions), choledochotomy (incision into the common bile duct) via coelioscopy, extraction of the basket, stent, and trapped gallstone as well as other stones in the common bile duct (cbd), luchka suturing of the duct, and placement of a kehr drain.The patient had a perioperative cholangiography and cholangioscopy as well.The medical device was recovered and set aside for possible expert analysis.The patient is reported to be doing well.A section of the device, the basket, remained inside the patient¿s body following the procedure, so the patient required surgery to remove the device.According to the reporter, the patient recovered following the surgery.

Manufacturer Narrative

Continued from occupation: non-healthcare professional.Continue from concomitant products: cook soehendra lithotriptor handle, slh-1.Cook soehendra lithotripsy cable, slc-2.Investigation evaluation: our photo and laboratory evaluation of the device confirmed the report.The device returned in three separate sections.A section containing the distal end of the basket measured approximately 84.5cm long was included in the return.The drive wire was broken and frayed at the proximal end of this section.The basket was misshapen.The other frayed drive wire section could not be measured due to the condition of the drive wire.The section containing the handle measured approximately 23.2cm.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.One of the pictures provided shows the device after use and surgical removal in addition to the device packaging.The photo shows all portions of the device except the catheter/sheath, the basket connected to the drive wire cable, a portion of the drive wire cable that appears to be the portion that was attached to the lithotripsy handle and the basket handle.The basket wires are deformed but still attached at the base and attached to the drive wire cable.The photo shows the handle and a small portion of drive wire cable where it was cut for lithotripsy.There is a break in the drive wire cable.The catheter is not present on any portion of the drive wire cable.A scan of the device label is also provided.The other image provided shows a fluoroscopic image of the device in the patient.The drive wire cable appears mangled and disconnected from the device handle.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.Evaluation 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.Due to the condition of the returned device we have concluded that the incident occurred during mechanical lithotripsy.The instructions for use for this device includes the following: "surgical intervention may be required if impaction occurs." the instructions for use of the sohendra lithotriptor handle warns, "due to the varying compositions of biliary stones, stone fracture may not be possible.If the stone cannot be fractured, continued rotation of the handle may cause the basket wire to break, requiring surgical intervention." prior to distribution, all web 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.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 emergent endoscopic retrograde cholangiopancreatography (ercp) with planned lithotripsy for acute cholangitis due to the stent having moved proximally to the stone and removal of a large gallstone in the common hepatic duct, the physician used a web extraction basket to extract the large gallstone.The basket wire broke and it was not possible to retrieve the basket, which remained stuck in the bile duct around the stone.A 12 cm plastic stent was placed proximally to the gallstone to drain the biliary ducts.The patient required surgery including adhesiolysis (removal of adhesions), choledochotomy (incision into the common bile duct) via coelioscopy, extraction of the basket, stent, and trapped gallstone as well as other stones in the common bile duct (cbd), luchka suturing of the duct, and placement of a kehr drain.The patient had a perioperative cholangiography and cholangioscopy as well.The medical device was recovered and set aside for possible expert analysis.The patient is reported to be doing well.A section of the device, the basket, remained inside the patient¿s body following the procedure, so the patient required surgery to remove the device.According to the reporter, the patient recovered following the surgery.

• Brand Name: THE WEB 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: 10113934
• MDR Text Key: 193622334
• Report Number: 1037905-2020-00232
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002227788
• UDI-Public: (01)10827002227788(17)211203(10)W4153089
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2021
• Device Catalogue Number: WEB-3X6
• Device Lot Number: W4153089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Date Manufacturer Received: 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PENTAX DUODENOSCOPE, UNKNOWN MODEL; PENTAX DUODENOSCOPE, UNKNOWN MODEL
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 73