MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® DIMENSION® STONE BASKET

Model Number	042313
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/23/2021
Type of Reportable Event	Serious Injury
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It was reported that when the stone basket was withdrawn from the renal pelvis into the ureter, the basket was torn off and remained in the ureter.According to the health care worker the basket could only be removed through open surgery.The initial procedure has been canceled.Per follow up information received on 29nov2021, according to the physician the ureter was torn off during the procedure.The patient was successfully operated on (b)(6) 2021.The remainder of the stone basket was recovered, and the ureter was replanted.
Event or Problem Description
It was reported that when the stone basket was withdrawn from the renal pelvis into the ureter, the basket was torn off and remained in the ureter.According to the health care worker the basket could only be removed through open surgery.The initial procedure has been canceled.Per follow up information received on 29nov2021, according to the physician the ureter was torn off during the procedure.The patient was successfully operated on (b)(6) 2021.The remainder of the stone basket was recovered, and the ureter was replanted.
Additional Manufacturer Narrative
The reported event was confirmed however the cause was unknown.The stone basket was returned with the original packaging.The basket tip was detached from the rest of the device.The basket was fully articulated and the thumb slide was fully retracted.The pinion knob was positioned at 7 o'clock instead of the 12 o'clock position.The sheath was cut and the shaft tubes were removed.It was noticed that the crimp joint holds the basket wires were still intact and the nitinol wire was noticed to be still attached to the shaft tubes with the crimp.The wires of the basket assembly exhibited elongation and stress.A potential root cause for this event would be, "inadequate crimp joint tube to tube." the device was used for treatment purposes.It was unknown if the device had met all relevant specifications.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "if resistance is encountered during advancement or withdrawal of the device, stop and determine the source of resistance, as continued resistance may damage the device and could result in patient injury.Take action to alleviate the resistance.Where necessary, use of a lithotrite may be required to reduce the stone burden within the basket, provided that no direct contact is made with the stone basket.Directions for use: only physicians trained in stone manipulation should perform this procedure.A variety of techniques may be employed; however the physician should use the technique most appropriate for the individual patient¿s situation.1.Inspect the device prior to use and during the procedure.2.Make sure the basket is closed by retracting the basket-tip into the sheath with the thumb slide (a).3.Insert the basket into the ureteroscope working-channel and advance the ureteroscope to the object to be removed.4.Under direct vision or fluoroscopic guidance, slowly advance the tip of the stone basket past the object." corrections: d,g,h h11: section a through f - the information provided by bd represents all 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.H3 other text : the actual/suspected device was inspected.

• Brand Name: BARD® DIMENSION® STONE BASKET
• Common Device Name: STONE BASKET
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12981416
• Report Number: 1018233-2021-07939
• Device Sequence Number: 4829521
• Product Code: FFL
• UDI-Device Identifier: 00801741066818
• UDI-Public: (01)00801741066818
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2022

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: 05/01/2023
• Device Model Number: 042313
• Device Catalogue Number: 042313
• Device Lot Number: BMCSMM15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2021
• Supplement Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 12/10/2021
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown