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

Model Number 041900

Device Problems Material Fragmentation (1261); Material Protrusion/Extrusion (2979)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/04/2020

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 piece of skylite 1.9fr nitinol basket was flecked off.

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.Visual evaluation of the returned sample noted one opened (within original packaging), used nitinol skylite stone basket with specimen cup.Visual inspection of the sample noted that there were blue particles seen on the frayed off basket wires.The filaments could not be seen between the tape pieces in the specimen cup.This does not meet the specification "scratches or foreign matter present are not permitted." the product caused the reported failure.A potential root cause for this failure mode could be ¿inadequate handling of material¿.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: "indications for use: this device is intended for use in endoscopic removal of ureteral and renal stones.Contraindications: none known warnings: ¿ some objects may be too large to be removed endoscopically using a retrieval device.The use of fluoroscopy and/or x-ray to determine the size of the object is recommended.Do not use the bard® skylitetm tipless nitinol stone basket if the object is too large to be removed endoscopically, as it may result in patient injury and pain.¿ this is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or may lead to injury, illness or death of a patient.¿ do not attempt to repair, reassemble, or alter the device in any way.¿ after use, this product will be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and with applicable laws and regulations.Follow your institutional guidelines.Caution: objects that are too large to be removed through the scope channel will require the scope and basket to be removed simultaneously from the urinary tract.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: before using, inspect for any breach of packaging to ensure sterility of product.Do not use if breach in sterile barrier is obvious or suspected.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.Potential complications that may result from the use of a basket in an endoscopic urological procedure include, but are not limited to: ¿ perforation ¿ evulsion ¿ edema ¿ entrapment ¿ laceration ¿ basket inversion ¿ hemorrhage ¿ inability to disengage from irretrievable object directions for use: only physicians trained in stone manipulation should perform this procedure.A variety of techniques may be employed; however the physician should use the technique most appropriate for the individual patient¿s situation." 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 actual/suspected device was inspected.

Event Description

It was reported that the pieces of nitinol basket was flecked off, and the pieces were retrieved.

• 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: 10919727
• MDR Text Key: 218723052
• Report Number: 1018233-2020-21245
• 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: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 041900
• Device Catalogue Number: 041900
• Device Lot Number: NGER4644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Date Manufacturer Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other