MAUDE Adverse Event Report: COOK INC WITTICH NITINOL STONE BASKET

Model Number	G05877
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common name: dislodger, stone, biliary.Pro code: lqr.Pma/510k #: k902944.Investigation ¿ evaluation: a review of the complaint history, device history record, drawing, manufacturing instructions, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the proximal hub (cap and adaptor) separated from the sheath material.A crease within the flare was noted, indicating the sheath material was caught between the cap and adaptor.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed the lot was released meeting all finished goods release criteria.It should be noted there was one other reported complaint for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be established.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.
Event or Problem Description
It was originally reported that the device valve separated from the catheter when the operator tried to pull the biliary stone out.No patient adverse events resulted from the malfunctioning of the device, and the complaint device was exchanged for a new device with no consequences for the patient.It was later discovered during the investigation of the returned device that it was the hub of the device which separated from the sheath material.
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: 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
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8354629
• Report Number: 1820334-2019-00456
• Device Sequence Number: 13931916
• Product Code: LQR
• UDI-Device Identifier: 00827002058774
• UDI-Public: (01)00827002058774(17)201110(10)8366076
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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 Expiration Date: 11/10/2020
• Device Model Number: G05877
• Device Catalogue Number: WNSB-12-24
• Device Lot Number: 8366076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 02/20/2019
• Supplement Report FDA Received Date: 08/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1