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 Consequences Or Impact To Patient (2199)
Date of Event	10/14/2018
Type of Reportable Event	Malfunction
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
It was reported a wittich nitinol stone basket was used for an unspecified stone removal procedure.During the procedure the middle of the basket wire was broken.The physician used a new product to complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Event or Problem Description
No new event description information to report at this time.
Additional Manufacturer Narrative
D10: product received on: 09nov2018.Investigation/evaluation: a review of the device history record, 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 wnsb basket set was returned for evaluation in used condition.The set included the gray tipped tubing (jcd-5.0-40-59.0-wnsb), blue sheath (rssw) and the gray tubing (trt-8.5).Each component contained biological matter on its surface.The tubing of the blue sheath appeared ¿wavy¿ towards the proximal hub.There were kinks noted on the gray tipped tubing, but on the gray tubing (jcd), there as a separation 50.3cm from the proximal end.The separated piece measured approximately 9.1cm.The basket was separated about halfway in the wire bundle.The separation occurred about 2cm from the basket.The silicone sphere and solder were present.No additional surface damage was noted on the wires.Dimensional analysis confirmed that the device and components were manufactured to the correct specifications and tolerances.Additionally, a document based investigation evaluation was performed.It has been found that there are sufficient controls in place to detect the failure mode prior to release to the customer.A review of the device history record showed no relevant nonconformances that could have contributed to this failure mode.It should be noted that no other complaints were reported for lot 8313011.The instructions for use (ifu) advise the user to inspect the product prior to use to ensure that no damage has occurred.Based on the information provided, examination of the returned product and the results of our investigation, a root cause could not be established.It is possible that user technique could have contributed to this event.Applying excessive torque while the stones are caught in the basket could cause a breakage in the wire strands, however, this factor could not be confirmed.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: 8015964
• Report Number: 1820334-2018-03221
• Device Sequence Number: 1382327
• Product Code: LQR
• UDI-Device Identifier: 00827002073135
• UDI-Public: (01)00827002073135(17)201023(10)8313011
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2019

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: 10/23/2020
• Device Model Number: N/A
• Device Catalogue Number: WNSB-8.5-50
• Device Lot Number: 8313011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2018
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 10/29/2018
• Supplement Report FDA Received Date: 01/04/2019
• 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: 9FR. SHEATH, WIRE GUIDE