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

Model Number	G05877
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported the sheath and hub separated on a wittich nitinol stone basket upon insertion.The device was removed and a new like device was used to complete the procedure as anticipated.There were no adverse consequences to the patient as a result of this reported issue.
Additional Manufacturer Narrative
This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Additional information was received from the customer.The procedure being performed was a biliary stone removal in the patient's chest region.The customer reportedly employs a 0.035¿ terumo wire guide for almost every procedure, and in this case may have used a 10 french or 11 french dilator size.Investigation - evaluation: a review of the complaint history, drawings, dimensional verification, device history record, documentation, instructions for use (ifu), manufacturing instructions, quality control, and visual inspection of the returned device was conducted during the investigation.The visual inspection of the returned device confirmed that the connector cap was physically disconnected from the sheath¿s flare.The flare was too damaged to be accurately measured.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, the definitive root cause was found to be user error in that the clinician did not use the appropriate sized dilator with the introducer sheath.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.

• Brand Name: WITTICH NITINOL STONE BASKET
• Common Device Name: LQR DISLODGER, STONE BILIARY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7442506
• Report Number: 1820334-2018-00782
• Device Sequence Number: 2053280
• Product Code: LQR
• UDI-Device Identifier: 00827002058774
• UDI-Public: (01)00827002058774(17)200919(10)8226824
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/27/2020

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
• Operator of Device: Health Professional
• Device Model Number: G05877
• Device Catalogue Number: WNSB-12-24
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/27/2018
• Supplement Date Received by Manufacturer: 05/23/2018; 08/04/2020
• Initial Report FDA Received Date: 04/19/2018
• Supplement Report FDA Received Date: 06/14/2018; 08/27/2020
• Patient Sequence Number: 1