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

Catalog Number WEB-2.5X5

Device Problems Fracture (1260); Unintended Collision (1429)

Patient Problems Obstruction/Occlusion (2422); Foreign Body In Patient (2687)

Event Date 07/24/2012

Event Type  Injury  

Manufacturer Narrative

Article citation: chan, c.H., donnellan, f., chan, g.C., & byrne, m.F.(2012).A novel two-step approach for retrieval of an impacted biliary extraction basket.Case reports in gastrointestinal medicine, 2012, 1-3.Doi:10.1155/2012/435050.Concomitant medical products: cook soehendra lithotripter, slh-1; cook soehendra lithotripsy cable, slc-2; cook conquest ttc lithotripter cable, ttcl-1 or ttcl-10.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.The report was confirmed with the pictures provided.The wires of the basket are bunched and impacted in the images in the report.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 the soehendra lithotriptor handle compatible with the web extraction basket for lithotripsy includes the following warnings: "due to mechanical pressure generated with this device, basket fragmentation in common bile duct is a possibility that may require surgical intervention.Do not remove sheath from basket wire.Doing so may result in basket fragmentation and consequently require surgical intervention.Due to varying compositions of biliary stones, stone fracture may not be possible.If stone cannot be fractured, continued rotation of handle may cause basket wire to break, requiring surgical intervention." the instructions for use for the soehendra lithotriptor handle compatible with the web extraction basket for lithotripsy includes the following instructions after stone has been fractured "release ratchet on handle of lithotripter to remove basket.Examine basket to confirm that it is not broken or damaged in any way, then dispose of basket per institutional guidelines for biohazardous medical waste." correct 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 web extraction basket."a diagnosis of obstructive jaundice secondary to choledocholithiasis was made and the patient proceeded to an ercp with planned removal of the sonographically visualized stone.Biliary cannulation was difficult.A needle knife fistulotomy was required to facilitate biliary access, and subsequent cholangiogram demonstrated a 10mm bile duct with an ill-defined 8mm filling defect in the mid duct.The fistulotomy orifice was extended with a sphincterotome, and a 25 mm extraction basket (the web extraction basket, cook inc, (b)(4), usa) was used to extract the stone.Surprisingly, despite the apparent size compatibility of the stone with distal duct and sphincterotomised orifice the basket became impacted within the intraduodenal portion of the bile duct (subject of this report).The plastic sheath covering the basket wire was cut exposing the free wires of the basket, and a mechanical extraendoscopic lithotriptor was used (soehendra lithotriptor, cook inc, (b)(4), usa).Upon cranking the lithotriptor, the [basket] wires fractured at the handle, outside the oral cavity (subject of this report).The duodenoscope (jf 180, olympus optical co ltd, (b)(4)) was then reinserted into the duodenum and biliary cannulation was reattempted around the basket.However, due to the local edema, no instruments beside a guidewire were able to be advanced beyond the stone/basket complex.A second attempt at mechanical lithotripsy was performed with the use of a shorter soehendra mechanical lithotriptor metallic sheath, but again, the wire fractured a second time at the handle.A decision was made to reattempt ercp 48 hours later to allow the local edema to settle.The procedure was abandoned, the basket wire secured with dressing forceps and surgical tape outside the oral cavity, and the patient placed on prophylactic antibiotics." the basket was left in the patient for 48 hours due to a decision to reattempt ercp later to allow the edema to settle.During the second ercp attempt, after dilation, rat-tooth forceps were used to dislodge the basket.A double pigtail stent was then placed, and the patient was discharge the next day.

• 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
• 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: 7876554
• MDR Text Key: 120262731
• Report Number: 1037905-2018-00415
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: WEB-2.5X5
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: OLYMPUS JF 180 OPTICAL ENDOSCOPE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR