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

Model Number 041900

Device Problem Material Fragmentation (1261)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Date 01/26/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the skylite basket was coming off.Per follow up with ibc via mail on 22dec2020, the equipment was used on a patient, when the basket was closed after having located the calculus, it was impossible to close it, and it got stuck.The device had to be pulled very hard, even torn off, and one end came off, to migrate.User took a second basket to recover the piece detached but same scenario happened when closing it (same lot).Fine biopsy forceps had to be used to retrieve the piece from the basket.

Manufacturer Narrative

The reported event was confirmed cause unknown.1 sample was confirmed to exhibit the reported failure.The device had not met specifications.The product was used for treatment.The product caused the reported failure.A potential root cause for this failure could be ¿part geometry¿.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: "1.Inspect the device prior to use and during the procedure for integrity and function.2.Make sure the basket is closed by retracting (pulling back) the basket tip into the sheath with the thumb slide as shown in figure b.3.With the basket closed, and using the optional introducer provided, carefully advance the distal portion of the closed device through the endoscope until it emerges out of the end of the endoscope.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.4.Once the object has been captured, partially close the basket to secure the object for removal by carefully pulling the thumb slide back.(refer to figure b).5.Slowly remove the basket and stone from the urinary tract.6.If the object is too large, you may need to simultaneously withdraw the basket and the ureteroscope from the urinary system.Directions for disassembly if handle disassembly is desired or required: 1.Squeeze bottom handle half at indicated points and pull down to remove handle bottom.2.Loosen thumbscrew until basket drive wire moves freely.3.Slide sheath and handle assembly over and away from drive wire." corrections: d,h.H11: section a through f - the information provided by bard 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 bard.H3 other text : the actual/suspected device was evaluated.

Event Description

It was reported that the skylite basket was coming off.Per follow up with ibc via mail on 22dec2020, the equipment was used on a patient, when the basket was closed after having located the calculus, it was impossible to close it, and it got stuck.The device had to be pulled very hard, even torn off, and one end came off, to migrate.User took a second basket to recover the piece detached but same scenario happened when closing it (same lot).Fine biopsy forceps had to be used to retrieve the piece from the basket.

• Brand Name: BARD SKYLITE TIPLESS NITINOL STONE BASKET
• Type of Device: SKYLITE BASKET
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11349023
• MDR Text Key: 232577194
• Report Number: 1018233-2021-00661
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00801741111518
• UDI-Public: (01)00801741111518
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 04/26/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 041900
• Device Catalogue Number: 041900
• Device Lot Number: NGDS2253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Initial Date Manufacturer Received: 01/26/2021
• Initial Date FDA Received: 02/19/2021
• Supplement Dates Manufacturer Received: 04/26/2021
• Supplement Dates FDA Received: 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention