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 Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2020

Event Type  malfunction  

Manufacturer Narrative

Additional procode: ffl- dislodger, stone, basket, ureteral, metal.Pma/510(k) #: k170898.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 stone basket was separated." these failures were observed with another device of the same lot.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Event Description

Additional information received on 20feb2020 confirmed the devices only separated at the hub.Basket separation did not occur.

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.

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.D10 ¿ product received on: 02mar2020 investigation ¿ evaluation a representative from seoul national university hospital informed cook of an incident involving a wittich nitinol stone basket.On (b)(6) 2020 during a procedure the sheath¿s hub separated.This occurred two times.No unintended section of the device remained inside the patient¿s body, 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, and quality control, as well as a visual inspection, and dimensional verification, were conducted during the investigation.The complainant returned two sheaths to cook for investigation.Physical examination of the returned device showed the two blue sheaths were returned 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 proper procedures are in place to identify and prevent this failure mode prior to device distribution.The risk specifications covering mac-loc drainage catheters include both hub separation and leakage as a potential failure mode.The identified risk controls include manufacturing quality control checks and process validation.The technical files covering mac-loc drainage catheters indicate that the risks associated with these devices are acceptable when weighed against the benefits.The device history record (dhr) for the complaint lot, the introducer sub-assembly lot, the tubing subassembly lots and the connector cap raw material lots records one relevant non-conformance.The non-conformance is for the fitting is not properly secured to the sheath.This affected a quantity of four that all had a disposition of scrapped.All introducers go through a 100% qc inspection for sheath to hub connection.A database search was completed on the complaint lot and an additional complaint captured under medwatch #1820334-2019-01343 for the same failure as this complaint was found.For medwatch #1820334-2019-01343, there was no evidence the device was manufactured out of specification or that there was evidence of non-conforming devices in house or out in the field.The product ifu, ¿wittich nitinol stone basket set,¿ provides the following information to the user related to the reported failure mode: instructions for use: ¿4.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).5.Remove the wire guide and dilator from the sheath, leaving the sheath in position.¿ though both flares of the device were damaged, this damage most likely occurred during the procedure when the hub separated from the tubing.Findings of this investigation revealed no evidence to suggest the devices were manufactured out of specification.Based on the information provided, inspection of returned product and the results of the investigation, it was concluded a component failure without a design or manufacturing deficiency contributed to this 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.

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 review of risk documentation indicated that this malfunction is not likely to cause serious injury if it were to reoccur.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.

• 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: 9721602
• MDR Text Key: 200258391
• Report Number: 1820334-2020-00395
• Device Sequence Number: 1
• Product Code: LQR
• UDI-Device Identifier: 00827002058774
• UDI-Public: (01)00827002058774(17)220221(10)NS9539988
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: NS9539988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Initial Date Manufacturer Received: 02/03/2020
• Initial Date FDA Received: 02/18/2020
• Supplement Dates Manufacturer Received: 02/20/2020; 06/01/2020; 07/23/2020
• Supplement Dates FDA Received: 02/28/2020; 06/05/2020; 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1