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 No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Additional common device name: ffl.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported an unknown patient required the use of a wittich nitinol stone basket for an unknown procedure.The operator reported the proximal hub and body of several stone baskets separated.It is unknown how many devices experienced this failure.As reported, the patient experienced no adverse effects.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.H6 ¿ method code: device not returned (4114).Investigation ¿ evaluation.(b)(6) hospital informed cook of an incident involving a wittich nitinol stone basket during a procedure the sheath¿s hub separated which was reported under medwatch report #: 1820334-2020-00395.During follow up with customer, it was reported that this failure occurred several times in the past.This report was submitted to capture the previously unreported incidents.The patient did not require additional procedures due to this occurrence and there have been no adverse effects to the patient due to this occurrence.A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control of the device were conducted during the investigation.The complainant did not return the complaint device to cook for investigation.Therefore, no visual inspection was performed.However, the devices for the originating complaint (medwatch report #: 1820334-2020-00395) were returned.The complainant returned two sheaths.Physical examination of the returned device showed the two blue sheaths were used with biomatter present.Both hubs were separated with damaged flares.No other damage was noted.All dimensions deemed relevant to the reported failure mode (sheath length, sheath tip id, sheath od) were analyzed and found that the devices were manufactured within specification.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.Product labeling was also reviewed.Instructions for use are packaged with this device.Relevant sections include: instructions for use: "insert the introducer sheath over the wire guide and across the percutaneous tract into anatomic structure.Position the radiopaque band of the sheath at or beyond the stone(s)." "remove the wire guide and dilator from the sheath, leaving the sheath in position.¿ cook could not complete a review of the device history record (dhr) due to lack of lot information from the user facility.A global sales shipment report was conducted from (b)(6) 2017 through (b)(6) 2020 for the complaint device.The customer bought 18 lots over this time period.A complaint database search was completed.There were 4 confirmed complaints on 6 devices from the 18 lots sold.None of the complaints found evidence that the devices were manufactured out of specification.Additionally, a non-conformance search was conducted on the 18 lots the customer bought.The dhr showed one related non-conformance that affected a quantity of one which was scrapped.All introducers go through a 100% inspection for sheath to hub connection, so at this time there is no evidence suggesting that nonconforming product exists in house or in the field.Findings of this investigation revealed no evidence to suggest the devices were manufactured out of specification.If excessive force was used on the sheath, it is possible the hub could separate from the tubing.Based on the information provided, no returned product for visual inspection, and results of the investigation, it was concluded that the cause is traced to a component failure without a design or manufacturing deficiency.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.

Manufacturer Narrative

Correction: this mdr is being submitted to indicate the event is not reportable.Upon further review, it was determined that this event is not reportable per 21cfr part 803.50 as it does not meet the criteria for a death, serious injury or reportable product malfunction.A review of reporting software revealed there are no previous incidents of hub separation of the rssw sheath that lead to a death or serious injury.Additionally, a review of risk documentation indicated that this malfunction is not likely to cause serious injury if it were to reoccur.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.

• 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: 10080392
• MDR Text Key: 198145761
• Report Number: 1820334-2020-00984
• Device Sequence Number: 1
• Product Code: LQR
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: K170898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: WNSB-12-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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