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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: unknown.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 a wittich nitinol stone basket broke during an unspecified procedure.Additional event details have not been received at this time.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
It was reported in additional information received on 13sep2013 that the device was implanted in the liver of the patient.The breakage happened after catching the stone and pulling back the basket.The physician attempted to remove the basket with forceps after it broke.It became impossible to retrieve via the ptc route.The hepatologist caught the basket, but it became stuck on the stent in the common bile duct.After thirty minutes of manipulation, the basket came out of the stent.Additional equipment used during the procedure included a 12fr sheath from arrow.
Event or Problem Description
It was reported in additional information received on 13sep2013 that the device was implanted in the liver of the patient.The breakage happened after catching the stone and pulling back the basket.The physician attempted to remove the basket with forceps after it broke.It became impossible to retrieve via the ptc route.The hepatologist caught the basket, but it became stuck on the stent in the common bile duct.After thirty minutes of manipulation, the basket came out of the stent.Additional equipment used during the procedure included a 12fr sheath from arrow.
Event or Problem Description
No new event description information to report at this time.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown or unavailable.Investigation - evaluation.A review of the device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, as well as a visual inspection and dimensional verification of the returned device was conducted during the investigation.One wittich nitinol stone basket was returned for investigation.The basket was mangled but intact.No breaks were noted to the basket, although no biomatter was noted.The silicone bead was still present but able to be moved along the basket wires.The solder joint was intact.The proximal end of the basket wire was broken.An introducer, sheath and tubing were returned with multiple kinks noted throughout.Dimensional analysis was conducted and confirmed that the device was manufactured within the correct specifications and tolerances.Additionally, a document based investigation evaluation was performed.The instructions for use (ifu) state that the basket set is intended for placement through a percutaneous tract for removal of stones or stone fragments from anatomic structures such as the gallbladder, biliary tract, renal pelvis and ureter.The document also instructs the use to inspect the device prior to use to ensure that no damage has occurred.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of returned product and the results of our investigation, it is possible that the cause could be traced to the user.If the silicone ball at the end of the nitinol basket were to get caught on the inside of the catheter or stent, it could move the silicone ball from its original place causing the basket to deform.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar events.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.

• 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: 7847839
• Report Number: 1820334-2018-02472
• Device Sequence Number: 1117013
• Product Code: LQR
• UDI-Device Identifier: 00827002073135
• UDI-Public: (01)00827002073135(17)210515(10)8886233
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K902944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/28/2018

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: 05/15/2021
• Device Model Number: N/A
• Device Catalogue Number: WNSB-8.5-50
• Device Lot Number: 8886233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Initial Date Received by Manufacturer: 08/14/2018
• Supplement Date Received by Manufacturer: 09/13/2018; 11/01/2018
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 10/09/2018; 11/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1