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

Model Number 041900

Device Problem Difficult to Open or Close (2921)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2020

Event Type  malfunction  

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 stone basket was opened all the way but it closed only partially before use.It was stated that since the product was not safe to use in the patient, user opened a new basket.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be "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: ¿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 thumb screw until basket drive wire moves freely.3.Slide sheath and handle assembly over and away from drive wire." 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.H3 other text : the device was not returned.

Event Description

It was reported that the stone basket was opened all the way but it closed only partially before use.It was stated that since the product was not safe to use in the patient, user opened a new 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: 11120370
• MDR Text Key: 243969603
• Report Number: 1018233-2020-22268
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2023
• Device Model Number: 041900
• Device Catalogue Number: 041900
• Device Lot Number: NGEW3783
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other