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

Model Number 041900

Device Problems Disconnection (1171); Material Fragmentation (1261)

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

Event Date 01/05/2021

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 basket was found to be broken when user opened it.Stated that the sliding switch that pull the basket in and out had fallen off.

Manufacturer Narrative

The reported event was confirmed however the cause was unknown.Visual evaluation of the returned sample noted one opened (without original packaging), used skylite nitinol stone basket with label.Visual inspection of the sample noted that the green thumb slider had fallen out of the handle.However, the green slider and the handle did not seem damaged.When the basket was reassembled, the basket still could not be opened or closed.This does not meet the specification as "assembly pattern must comply with drawing and visual aid".A potential root cause for this failure could be ¿lack of epoxy /adhesive / cure time¿.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: ¿insertion 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." the actual/suspected device was inspected.

Event Description

It was reported that basket was found to be broken when user opened it.It was stated that the sliding switch that pull the basket in and out had fallen off.Per sample evaluation, when the sample was reassembled, the stone basket was still unable to open.

• Brand Name: BARD SKYLITE TIPLESS NITINOL STONE BASKET
• Type of Device: NITINOL BASKET
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11225700
• MDR Text Key: 228623692
• Report Number: 1018233-2021-00105
• 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: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 06/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 041900
• Device Catalogue Number: 041900
• Device Lot Number: NGEX0075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Date Manufacturer Received: 06/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other