MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® PLATINUM CLASS¿ II FLAT WIRE STONE BASKET

Model Number	045390
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.
Event or Problem Description
It was reported that the basket would not close.Another device was used.There was no patient injury reported.
Event or Problem Description
It was reported that the basket would not close.Another device was used.There was no patient injury reported.
Additional Manufacturer Narrative
The reported event was confirmed as use related.The evaluation report of the returned sample, submitted by omnitech systems, states that the lock knob that holds the control wire of the basket to the actuating thumbslide was loosened thereby making the unit inoperable.When the lock knob was torqued back to manufacturing standards, the device performed as designed.The root cause of this failure is that user was unfamiliar with the device or procedure.A device history record review was not required per the investigation.The instructions for use were found adequate and state the following: "only physicians trained in stone manipulation should perform this procedure.A variety of techniques in the use of this instrument may be employed; however, the physician should use the technique with which he/she is most familiar.Inspect the device prior to use and during the procedure.Retract instrument tip into sheath.In the closed position, insert the instrument into the ureteroscope working channel and advance the ureteroscope into the ureter or renal pelvis.With the basket closed/retracted, advance the instrument to the object to be removed.Push forward on thumb control knob to advance basket between object and ureteral wall.Once the object has been captured, partially close the basket to secure the object for removal.Simultaneously withdraw the basket and the ureteroscope from the urinary system.Handle disassembly/reassembly: if handle removal is desired: unscrew the thumb screw located on the basket handle.Gently pull backward on the handle, releasing both the handle and sheath from the drivewire/basket combination.If any resistance is felt at this stage, stop and determine cause of resistance.Once the stone burden within the basket has been removed, the basket can be closed using an open tip ureteral catheter.The basket can be reassembled easily by inserting the drivewire into the sheath and advancing until it reaches the handle.Tighten the thumb screw to secure the drivewire in place." h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: BARD® PLATINUM CLASS¿ II FLAT WIRE STONE BASKET
• Common Device Name: STONE BASKET
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9417539
• Report Number: 1018233-2019-07746
• Device Sequence Number: 524566
• Product Code: FFL
• UDI-Device Identifier: 00801741066900
• UDI-Public: (01)00801741066900
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2020

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: 05/01/2021
• Device Model Number: 045390
• Device Catalogue Number: 045390
• Device Lot Number: BMASMM05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 02/07/2020
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 02/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1