MAUDE Adverse Event Report: COOK INC N-COMPASS NITINOL STONE EXTRACTOR; LQR DISLODGER, STONE BILIARY

Model Number N/A

Device Problems Material Separation (1562); Firing Problem (4011)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/16/2022

Event Type  malfunction  

Event Description

It was reported that the possible basket separation in a n-compass nitinol stone extractor may have led to portions of the device being left behind in an unknown patient during a choledochoscopy and common bile duct stone extraction.The patient underwent the extraction procedure for 5mm to 6mm stones that were mobile in the common bile duct.Before inserting the device into the choledochoscope outside of the patient, the three wire tipped basket was opened from it's packaging and checked for functionality.The device was reported to have functioned as expected.The basket was advanced through the choledochoscope without difficulty.As the operator advanced the device beyond the stone and opened the basket, a "snap" sound was heard.As a choledochoscope was used, the operator had direct vision; however, basket deployment was not visualized because it was beyond the stone, out of view.The basket was then removed from the choledochoscope, and upon use of the thumb mechanism of the device, there was no basket deployment.The operator was unsure if the internal mechanism had broken, with the basket retained inside of the device, or if the basket had snapped off and remained in the body of the patient.An x-ray and ct scan were performed on the patient, but there was no evidence of the basket on the view.A second like device was opened to complete the procedure successfully.Following the procedure, the nurse loosened the black screw on the handle of the device in an attempt to visualize the basket; however, the basket was still unable to be found.At the time of this report, the patient has not experienced any adverse effects or required any additional procedures due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Customer (person): phone: 07 53165435.Occupation: unknown.Pma/510(k): k173009.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Additional information was provided indicating that an endoscopic retrograde cholangiopancreatography (ercp) was performed, which confirmed no portion of the device was retained in the patient.

Manufacturer Narrative

This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Investigation ¿ evaluation caboolture public hospital (australia) informed cook on 17aug2022 of an issue with a c-ntse-2.4-115-nc3 (n-compass nitinol stone extractor) from lot 14325032.The customer stated the device went through the choledocoscope with no issue, then the device was advanced beyond the stone.When the operator attempted to open the basket, a snap sound was heard.The operator is unsure if the basket is (still) inside the device or if the basket has snapped off and remains in the patient.A replacement device was used to complete the procedure.No adverse effects to the patient have been reported.Further communication with the customer stated an endoscopic retrograde cholangiopancreatography (ercp) was performed, which confirmed no portion of the device was retained in the patient.Reviews of documentation including the complaint history, device history record (dhr), quality control, and instructions for use (ifu), as well as a visual inspection of the returned device, were conducted during the investigation.One used device was received.Upon testing, the basket was located intact inside the sheath.The sheath was cut transversely a few cm from the distal end, and later cut longitudinally to free the basket.The basket was closed within the sheath and opened upon cutting the sheath.No damage to the basket was noted.Cook has concluded that the device was manufactured to specification.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhrs for the reported complaint device lot revealed no non-conformances.A database search did not identify any other events associated with the reported device lot.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The product ifu, [t_ncnse_rev1] ¿ncompass nitinol stone extractors,¿ provides the following information to the user related to the reported failure mode: ¿contradictions -this device is not intended for use within endoscopic retrograde cholangio-pancreatogrpahy (ercp) procedures.Instructions for use -remove the stone extractor from its outer package and move the thumb tab on the handle to the ¿close¿ position to close the basket.-insert the stone extractor either through the working channel of the choledochoscope or a lumen of an ancillary device used to access the bile duct (for example, a cholangiography catheter or dilation balloon with a working channel of 2.4 french or greater).Note: the provided tuohy-borst adapter, featuring a distal luer lock connector, may be attached to the proximal end of the ancillary device prior to the insertion of the stone extractor, if desired.-advance the stone extractor into the duct and position the distal end beyond the stone or debris.Note: under fluoroscopic monitoring, the tip of the tipped stone extractor (c-ntse-2.4-115-nc3) may be visualized.-after confirming that the extractor is positioned alongside or beyond the stone/debris, open the basket by sliding the thumb tab to ¿open¿ position.-maneuver and manipulate the open basket to capture the stone or debris.-once captured, slowly transition the thumb tab toward the ¿close¿ position to secure the stone or debris.-maintain pressure on the thumb tab of the handle to hold the stone or debris in place.Slowly retract the stone extractor and the ancillary device (or scope if utilized) together to facilitate the immediate removal of object from the tract.Note: the provided tuohy-borst adapter may be tightened once the stone is captured to secure the position of the stone extractor during removal.This adapter will not lock the basket on the stone or debris, but will secure the position of the sheath relative to the ancillary device.Note: do not use excessive force on the handle.Doing so may result in damage to the device, including but not limited to, basket separation or inability to open/close device.How supplied supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened and undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the available information, inspection of the returned device, and the results of the investigation, cook concluded the cause of event is component failure unrelated to manufacturing or design deficiencies.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: N-COMPASS NITINOL STONE EXTRACTOR
• Type of Device: LQR DISLODGER, STONE BILIARY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC.; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 15292501
• MDR Text Key: 298568122
• Report Number: 1820334-2022-01401
• Device Sequence Number: 1
• Product Code: LQR
• UDI-Device Identifier: 10827002362502
• UDI-Public: (01)10827002362502(17)240701(10)14325032
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-NTSE-2.4-115-NC3
• Device Lot Number: 14325032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2021
• 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: STORZ FLEX VIDEO CHOLEDOCOSCOPE 3FG MODEL 11292VS.
• Patient Outcome(s): Other