MAUDE Adverse Event Report: COOK ENDOSCOPY SOEHENDRA LITHOTRIPTOR HANDLE; LQC, LITHOTRIPTER, BILIARY MECHANICAL

Catalog Number SLH-1

Device Problems Accessory Incompatible (1004); Mechanical Problem (1384); Use of Device Problem (1670)

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

Event Date 10/02/2016

Event Type  Injury  

Manufacturer Narrative

The investigation is on-going.A follow-up emdr will be sent following the completion of the investigation.Bhanthumkomol, p., aswakul, p., & prachayakul, v.(2016).Argon plasma coagulation for the resolution of basket impaction from large common bile duct stones.Endoscopy international open, 4(4), e389¿e390.Https://doi.Org/10.1055/s-0042-100905.

Event Description

Cook endoscopy was notified of this event via an article found by cook regulatory affairs.The article was published in 2016.Please see below for relevant excerpts of this article.¿a (b)(6) year-old man, with no pre-existing illness, presented with abdominal pain, fever, and jaundice of several days¿ duration¿.Liver chemistries showed increased total and direct bilirubin levels of 5.6 and 4.8mg/dl, respectively; aspartate transaminase of 45 u/l; alanine transaminase of 42 u/l; and an elevated alkaline phosphatase level of 321 u/l.Computed tomography showed four large (1.5¿2.0cm) stones in the cbd.For this procedure, performed 1 week later, the patient was placed in a left lateral decubitus position and intravenous anesthesia (propofol) was administered.Following duodenal intubation and cbd cannulation with a standard sphincterotome, a cholangiogram was obtained that revealed a dilated cbd (1.5¿2.2 cm) and four filling defects, shaped like polygons, located in the mid to distal portion.The three distally located cbd stones were successfully removed with a dormia basket.During an attempt to remove the last stone, the basket-stone complex was impacted at the intraduodenal portion of the cbd and could not be pulled out into the duodenum.This impaction also blocked insertion of the catheter for a large balloon dilation procedure.Therefore, mechanical lithotripsy was attempted with a soehendra lithotripter.However, this failed because of device malfunction.The basket-stone complex was then manipulated with rat-tooth forceps; however, this also failed, even after extended sphincterotomy.Subsequent attempts to push the basket¿ stone complex back into the proximal cbd with an extraction balloon similarly failed.Next, we decided to use apc (100w, force mode) to cut two of the four basket wires and release the basket-stone complex.The basket was released from the impacted stone and retrieved easily by pulling it back into the duodenoscope.Finally, a 10-fr double-pigtail stent (5 cm in length) was inserted across the distal cbd, and the procedure was terminated¿ the impacted basket was removed using argon plasma coagulation (apc).A 10-fr double-pigtail stent (5 cm in length) was placed and the procedure was completed.The patient was rescheduled to undergo stone clearance 3 months later.

Manufacturer Narrative

Bhanthumkomol, p., aswakul, p., & prachayakul, v.(2016).Argon plasma coagulation for the resolution of basket impaction from large common bile duct stones.Endoscopy international open, 4(4), e389¿e390.Https://doi.Org/10.1055/s-0042-100905 investigation evaluation: a product evaluation was performed only by the picture and video provided in response to this report because the product said to be involved was not provided to cook for evaluation.Per the photo and video 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 video in the article shows the use of an argon plasma coagulation catheter to cut the basket wires, and the picture shows a cholangiogram showing multiple large stones in the common bile duct.The video and picture are 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 device was used with an incompatible basket (use error).The report indicates a dormia basket was used.The instructions for use (ifu) warns, "only select cook biliary soft wire baskets are recommended for use with this device." use with an incompatible basket is the likely root cause of the device failure.Prior to distribution, all soehendra lithotriptor handles are subjected to a visual inspection and functional testing to ensure device integrity.Corrective action: 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 LITHOTRIPTOR HANDLE
• Type of Device: LQC, LITHOTRIPTER, BILIARY MECHANICAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 12081091
• MDR Text Key: 269730210
• Report Number: 1037905-2021-00281
• 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: foreign,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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SLH-1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/03/2021
• Initial Date FDA Received: 06/28/2021
• Supplement Dates Manufacturer Received: 06/28/2021
• Supplement Dates FDA Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ENDOSCOPE, UNKNOWN MAKE OR MODEL
• Patient Outcome(s): Required Intervention
• Patient Age: 93 YR