MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® SKYLITE¿ TIPLESS NITINOL STONE BASKET

Catalog Number	041900
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/07/2024
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.Udi format updated with available product information per gudid.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.
Event or Problem Description
It was reported that they had received the technovigilance notification reported by nurse and having the justification of the surgeon regarding the basket that presented the technical complaint during the procedure of the patient on (b)(6) 2024 surgical block of hospital.It was necessary to use another unit to continue the procedure.It was not possible to store the product as it was contaminated.Per additional information received on 17apr2024, stated that during the laser ureterolithotripsy procedure, the basket disintegrated so that it did not perform its function.A metal fragment of the basket material remains on the floor of the ureter.For this reason, a new basket was used, and all fragments were removed successfully from the ureter.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.Root cause could not be identified.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be "part geometry material selection".However, there was insufficient information to confirm this potential root cause.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: "caution: 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.Precautions: do not allow the device to come in contact with any electrified instruments or laser.Kinks in the sheath will hinder the mechanical operation of the basket, may affect insertion or withdrawal of the basket and has the potential to damage the endoscope¿s instrument channel.Do not allow the device to be directly fired upon by any lithotripsy devices.To do so may result in damage to the device and could result in patient injury." udi format updated with available product information per gudid.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.
Event or Problem Description
It was reported that they had received the technovigilance notification reported by nurse and having the justification of the surgeon regarding the basket that presented the technical complaint during the procedure of the patient on (b)(6) 2024 surgical block of hospital.It was necessary to use another unit to continue the procedure.It was not possible to store the product as it was contaminated.Per additional information received on 17apr2024, stated that during the laser ureterolithotripsy procedure, the basket disintegrated so that it did not perform its function.A metal fragment of the basket material remains on the floor of the ureter.For this reason, a new basket was used, and all fragments were removed successfully from the ureter.

• Brand Name: BARD® SKYLITE¿ TIPLESS NITINOL 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 GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 20126484
• Report Number: 1018233-2024-05376
• Device Sequence Number: 16960275
• Product Code: FFL
• UDI-Device Identifier: 00801741111518
• UDI-Public: (01)00801741111518(11)230110(17)251130(10)NGGZ2502
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2024

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: 11/30/2025
• Device Catalogue Number: 041900
• Device Lot Number: NGGZ2502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2023
• 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 Age: 69 YR
• Patient Sex: Female