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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Code Available (3191)
Date of Event	10/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional procode: ffl.(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 an unknown patient required a wittich nitinol stone basket for a biliary stone removal after percutaneous transhepatic biliary drainage procedure.During the procedure, the operator grabbed the stone and pulled it toward the sheath.While pulling the basket, the sheath separated from the hub.The separated "parts" were recovered from the patient.No other adverse effects were reported for this incident.
Additional Manufacturer Narrative
Correction: this report is being sent to indicate the complaint event is not reportable.Additional information provided 02nov2020 stated no section of the device remained in the patient.The photo provided did not appear to show risk of requiring intervention to retrieve the separated component.Therefore, upon further investigation, this event is not reportable.There is no information confirming device malfunction or serious injury.A review of risk documentation does not indicate that this event is likely to cause serious injury if it were to reoccur.As there are no recorded incidences of serious injury due to the complaint event, and it is not likely that serious injury would result if the event were to recur, per 21cfr part 803.50 the complaint event is considered not reportable.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
• Common Device Name: LQR DISLODGER, STONE BILIARY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10787292
• Report Number: 1820334-2020-02010
• Device Sequence Number: 11670123
• Product Code: LQR
• UDI-Device Identifier: 00827002058774
• UDI-Public: (01)00827002058774(17)230318(10)13063282
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K170898
• 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
• Report Date (Section B): 11/25/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/18/2023
• Device Model Number: N/A
• Device Catalogue Number: WNSB-12-24
• Device Lot Number: 13063282
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN MANUFACTURER 12FR INTRODUCER; UNKNOWN MANUFACTURER 12FR INTRODUCER
• Outcome Attributed to Adverse Event: Other; Required Intervention