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

Model Number 041900

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/06/2022

Event Type  Injury  

Event Description

It was reported that the device was broken when doctor retrieved the stone basket and pulled it out from patient.The doctor was concerned that if there were any broken piece of foreign body left into patient.Also stated to advise the length of the device.Per follow-up information received via ibc on (b)(6) 2022, stated that one wire of basket was broken and incomplete.Doctor thought that the broken piece left inside the patient.They have checked the x-ray; however, nothing could be found.Also believed the broken wire was so small and thin to be find and see.Therefore, they would like to know the length of the basket.And can know that if the basket wire was incomplete and have missing part.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Manufacturer Narrative

The reported event was confirmed cause unknown.One sample was confirmed to exhibit the reported failure.The device has not met specification.The product was used for treatment.The product has caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used nitinol stone basket.Visual inspection of the sample noted the device was broken.Further, inspection noted the wire basket was broken into two pieces.The photo sample provided shows the broken wire basket.This does not meet specifications which states "the basket assembly shall comply with drawing".A potential root cause for this event could be "part geometry material selection".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: "capture and removal 1.Under direct vision or fluoroscopic guidance, slowly advance the basket tip past the object.2.Open the basket by pushing the thumb slide forward.(refer to figure b).3.Pull the basket backward toward the object while slowly rotating the basket as necessary." corrections: d, g.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 evaluated.

Event Description

It was reported that the device was broken when doctor retrieved the stone basket and pulled it out from patient.The doctor was concerned that if there were any broken piece of foreign body left into patient.Also stated to advise the length of the device.Per follow-up information received via ibc on 13-dec-2022, stated that one wire of basket was broken and incomplete.Doctor thought that the broken piece left inside the patient.They have checked the x-ray; however, nothing could be found.Also believed the broken wire was so small and thin to be find and see.Therefore, they would like to know the length of the basket.And can know that if the basket wire was incomplete and have missing part.

• Brand Name: BARD® SKYLITE¿ TIPLESS NITINOL STONE BASKET
• Type of Device: NITINOL 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16067738
• MDR Text Key: 306331567
• Report Number: 1018233-2022-09968
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00801741111518
• UDI-Public: (01)00801741111518
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 041900
• Device Catalogue Number: 041900
• Device Lot Number: NGEU2978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other