MAUDE Adverse Event Report: COOK ENDOSCOPY SOEHENDRA LITHOTRIPSY CABLE; LQC, LITHOTRIPTER, BILIARY MECHANICAL

Catalog Number UNKNOWN

Device Problems Accessory Incompatible (1004); Use of Device Problem (1670); Mechanical Jam (2983)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

The investigation is on-going.A follow-up emdr will be sent following the completion of the investigation.Mukhija, d., nagpal, s.J., parsi, m., chahal, p., & sanaka, m.(2014).Impacted stone retrieval basket and lithotripter: an unusual complication of ercp for choledocholithiasis.The american journal of gastroenterology, 109(2).

Event Description

Cook endoscopy was notified of this event via an abstract found by cook regulatory affairs.The article was published in 2014.Please see below for relevant excerpts from this abstract: ¿a (b)(6)-year-old female with a history of laparoscopic cholecystectomy was referred for ercp for choledocholithiasis.Cholangiogram confirmed a 15-mm stone in the mid common bile duct.However, the procedure was complicated by the impaction of a flower basket which failed to resolve even after dilatation of the distal cbd to 15 mm using a balloon dilator.A soehendra mechanical lithotripter [soehendra lithotriptor cable] was then inserted along the basket wires and lithotripsy was attempted.Unfortunately, the lithotripter [soehendra lithotriptor cable] also got impacted in the bile duct over the basket and could not be pulled out.The presence of the basket and the wire precluded the placement of a biliary stent at this time but good bile flow was seen and the procedure was aborted.The basket and lithotripsy wires were cut and secured at the patient¿s mouth.At repeat ercp 3 days later, attempts to drag the impacted devices and stone with an extraction balloon were unsuccessful.Electrohydraulic lithotripsy (ehl) was then performed and the stone was fragmented.Then a rat-tooth forceps was passed into the bile duct under endoscopic and fluoroscopic guidance, and the impacted basket and lithotripter could now be pulled out.An extraction balloon was then used to clear the bile duct and a temporary biliary stent was inserted to ensure biliary drainage.The patient did well without any further complications.¿ the impacted device temporarily remained inside the patient¿s body, but was successful removed after ehl followed by retrieval with rat-tooth forceps under fluoroscopic guidance.It was published that the wires were cut on the basket and lithotripsy and an additional ercp procedure was performed and the devices were removed successfully.According to the article, the patient did not experience any adverse effects due to this occurrence.The patient did well without any further complications.

Manufacturer Narrative

Mukhija, d., nagpal, s.J., parsi, m., chahal, p., & sanaka, m.(2014).Impacted stone retrieval basket and lithotripter: an unusual complication of ercp for choledocholithiasis.The american journal of gastroenterology, 109(2).Investigation evaluation: a product evaluation was performed only by the picture provided in response to this report because the product said to be involved was not provided to cook for evaluation.Per the photo 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 picture in the article shows a fluoroscopic image of the procedure.The picture is inconclusive for the reported occurrence.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusion: the article indicated that the device was used with a flower basket.The ttcl-1, ttcl-10, and slc-2 devices are not recommended for use with flower baskets as indicated in the ifu.Use of this device with an incompatible basket is the most likely cause of the reported issue.The ifu for the ttcl-1 & ttcl-10 states, "used in conjunction with a side-viewing endoscope, cook endoscopy lithotripsy-compatible baskets and a soehendra lithotriptor handle.¿ it also says, ¿only specified cook endoscopy soft lithotripsy-compatible baskets are recommended for use with the conquest ttc lithotriptor cable.Refer to basket label.¿ the ifu for the slh-2 states, "only select cook biliary soft wire baskets are recommended for use with this device." the article reported occurrences of impaction during stone extraction.Impaction of the device is a known complication of these types of procedures.The instructions for use includes the following potential complications, "those associated with basket extraction include, but are not limited to: impaction of the object, localized inflammation, pressure necrosis." prior to distribution, all lithotriptor cables are subjected to a visual inspection to ensure device integrity.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.

• Brand Name: SOEHENDRA LITHOTRIPSY CABLE
• Type of Device: LQC, LITHOTRIPTER, BILIARY MECHANICAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 12091461
• MDR Text Key: 259137714
• Report Number: 1037905-2021-00288
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• PMA/PMN Number: K902170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ENDOSCOPE, UNKNOWN MAKE OR MODEL; FLOWER EXTRACTION BASKET; ENDOSCOPE, UNKNOWN MAKE OR MODEL; FLOWER EXTRACTION BASKET
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR