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

Model Number 041900

Device Problems Device Inoperable (1663); Difficult to Open or Close (2921)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/28/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.The device was not returned.

Event Description

It was reported that the basket did not open or close in the ureter as the doctor attempted to remove the stone fragments.

Manufacturer Narrative

The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: ¿the bard® skylitetm tipless nitinol stone basket consists of a handle to open, close and rotate the basket, a flexible polyimide shaft and a 4-wire nitinol stone basket.The package includes one (1) basket and one (1) introducer.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.Insertion: inspect the device prior to use and during the procedure for integrity and function.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.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: under direct vision or fluoroscopic guidance, slowly advance the basket tip past the object.Open the basket by pushing the thumb slide forward.(refer to figure b).Pull the basket backward toward the object while slowly rotating the basket as necessary.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).Slowly remove the basket and stone from the urinary tract.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: squeeze bottom handle half at indicated points and pull down to remove handle bottom.Loosen thumbscrew until basket drive wire moves freely.Slide sheath and handle assembly over and away from drive wire.¿ (b)(4).The device was not returned.

Event Description

It was reported that the basket did not open or close in the ureter as the doctor attempted to remove the stone fragments.

Manufacturer Narrative

Received 1 used tipless nitinol stone basket.The reported issue was confirmed.During the visual evaluation, it was noted that some sections had kinks.The sample was received with the basket closed.The internal assembly of the handler did not present any discrepancies.Per functional test, the basket could not open.The dimensional assessment found the sample within specification.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use 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.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 device was not returned.

Event Description

It was reported that the basket did not open or close in the ureter as the doctor attempted to remove the stone fragments.

• Brand Name: BARD® SKYLITE¿ TIPLESS NITINOL STONE BASKET
• Type of Device: GUIDEWIRE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7138234
• MDR Text Key: 95961139
• Report Number: 1018233-2017-06436
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: 041900
• Device Catalogue Number: 041900
• Device Lot Number: NGZC3831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Date Manufacturer Received: 04/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1