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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Date 10/28/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported an unknown patient required a wittich nitinol stone basket to remove a biliary stone.After the device secured the stone, it was pulled towards the sheath.Per the initial report, "the product was disconnected while pulling the basket." additional intervention was required to recover the separated parts.No other adverse effects were reported for this incident.Additional information regarding event details has been requested but is unavailable at the time of this report.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.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 received on (b)(6) 2019 confirmed there were no additional procedures performed, fractured portion was recovered during the original procedure.

Manufacturer Narrative

D10: product received on: 04dec2019.Investigation / evaluation: (b)(6) from (b)(6) hosp.Informed cook of an incident involving a wittich nitinol stone basket.On (b)(6) 2019, during a biliary stone removal procedure the physician grabbed the stone and pulled it towards the sheath.The product was disconnected while pulling the basket.No resistance was felt during insertion or removal of any of the components.No additional procedures were performed; the fractured portion was recovered during the original procedure.The procedure was terminated and there was no follow-up with the patient.A review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device, as well as a visual inspection and dimensional verification, were conducted during the investigation.The complainant returned one damaged wittich nitinol stone basket to cook for investigation.Physical examination of the returned device showed separation at the notched cannula that connects the basket assembly to the stylet wire.No other surface damage was present.Additionally, a document based investigation evaluation was performed.The risks associated with these devices are acceptable when weighed against the benefits.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device history record (dhr) for complaint lot revealed reported nonconformances.Three of the non-conformances were determined to be related to this issue.All non-conformances were either reworked or scrapped.A database search revealed no other complaints have been reported for the device lot.There is no evidence the device was not manufactured to specification, or that there are nonconforming devices in house or out in the field.The device instructions for use (ifu) was reviewed.It warns, ¿upon removal from the package, inspect the product to ensure no damage has occurred.¿ it is possible if there is too much stress on the wire, this may have caused the wire to separate.However, based on the information provided, returned product and the results of the investigation, it was concluded a component failure without a manufacturing or design defect contributed to the failure mode.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook 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 the patient and/or event 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
• MDR Report Key: 9311813
• MDR Text Key: 166050063
• Report Number: 1820334-2019-02850
• Device Sequence Number: 1
• Product Code: LQR
• UDI-Device Identifier: 00827002058774
• UDI-Public: (01)00827002058774(17)220221(10)9539986
• Combination Product (y/n): N
• PMA/PMN Number: K902944
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2022
• Device Model Number: N/A
• Device Catalogue Number: WNSB-12-24
• Device Lot Number: 9539986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Initial Date Manufacturer Received: 10/29/2019
• Initial Date FDA Received: 11/12/2019
• Supplement Dates Manufacturer Received: 12/02/2019; 01/27/2020
• Supplement Dates FDA Received: 12/31/2019; 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention