MAUDE Adverse Event Report: COOK INC WITTICH NITINOL STONE BASKET; LQR DISLODGER, STONE BILIARY

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/26/2023

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Additional common name: ffl dislodger, stone, basket, ureteral, metal.Additional product code: ffl.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

It was reported that the wittich nitinol stone basket "disconnected" when being pulled during a biliary stone removal following a percutaneous transhepatic biliary drainage (ptbd) procedure.The included 12fr introducer was used to place the device.The stone was grabbed by the basket and then pulled towards the sheath.It was then that the basket body separated from the sheath.No resistance was experienced during insertion or removal of the device.An additional intervention was required to remove separated products from the patient.Patient activity level was described as "free moving." additional information regarding event details has been requested but is currently unavailable.

Event Description

Per additional information received, basket retrieval was performed when the basket was removed with the sheath.No additional procedures were performed.

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.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.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation: it was reported by (b)(6) hospital (republic of korea) that a wittich nitinol stone basket (rpn: wnsb-8.5-50; lot#: ns14965812) separated.The device was required for biliary stone removal following a percutaneous transhepatic biliary drainage procedure.The 12 french introducer and dilator supplied with the device were used to place the basket.There was no resistance inserting the basket.A stone was grabbed with the basket and the device was pulled towards the sheath.At this time, the basket separated from the dilator.No resistance was felt during removal of the device.A photo was provided which appears to show separation at the metal wire and basket separated from the loading sleeve of the device.The separated component was removed from the patient with the sheath.No other procedures or adverse effects were reported.Reviews of the documentation, including the complaint history, device history record, instructions for use (ifu), manufacturing instructions and quality control procedures of the device, were conducted during the investigation.The complaint device was not returned for evaluation; therefore, no physical examination could be conducted.However, a photo of the complaint device was provided by the customer and showed that the breakage was likely in the wire bundle.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 prior to distribution.A review of the device history record (dhr) for lot ns14965812 found no relevant nonconformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with the product lot number.Cook also reviewed product labeling.The instructions for use (ifu) [t_wnsb_rev] supplied with complaint device were reviewed for information related to the reported failure mode.The ifu states: ¿instructions for use: 6.Slide the loading sleeve down the basket catheter to cover the basket portion of the basket catheter.7.Insert the loading sleeve and basket catheter into the hub of the introducer sheath.8.Advance the basket catheter through the sheath and position the basket beyond the stone.9.Rotate and withdraw the basket catheter at the level of the stone(s) to position/capture the stone(s) within the basket.10.Once the stone(s) are captured, withdraw the basket and sheath from the tract¿ how supplied.Upon removal from the package, inspect the product to ensure no damage has occurred.¿ evidence gathered from a review of the dmr, product labeling, dhr, and provided photo, does not indicate the device was manufactured out of specification.There is no evidence of nonconforming material in house or in the field.Based on the information provided, examination of a photo provided by the customer, and the results of our investigation, it was concluded that a component failure unrelated to manufacturing or design deficiencies contributed to this event.It is possible that too much force was used during one of the retrievals, but cook cannot confirm this without more information.The appropriate personnel have been notified.Per the risk assessment no further action is required.We will continue to monitor for similar complaints.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 patient and/or event details has been received since the previous medwatch report was sent.

• Brand Name: WITTICH NITINOL STONE BASKET
• 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: 16280742
• MDR Text Key: 308606340
• Report Number: 1820334-2023-00086
• Device Sequence Number: 1
• Product Code: LQR
• UDI-Device Identifier: 00827002073135
• UDI-Public: (01)00827002073135(17)250920(10)NS14965812
• Combination Product (y/n): N
• PMA/PMN Number: K170898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• 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: WNSB-8.5-50
• Device Lot Number: NS14965812
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2022
• 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
• Patient Outcome(s): Required Intervention