MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® PLATINUM CLASS¿ II FLAT WIRE STONE BASKET; BARD FLATWIRE STONE BASKETS

Model Number 045290

Device Problem Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/29/2017

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 a part of the medical device was torn.The operator was obliged to remove it with a clamp and use an other medical device.

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: "description: the flat wire stone basket consists of three main assemblies: handle, shaft and basket.Indications for use: this device is intended for use in the endoscopic removal of renal and ureteral stones.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 platinum class flatwire basket if the object is too large to be removed endoscopically.After use this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and applicable laws and regulations.This is a single use device.Do not re-sterilize 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 lead to injury, illness or death of the patient.Cautions: objects that are too large to be recovered through the sheath or 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.Where necessary, use of a lithotrite may be required to reduce the stone burden within the basket, provided that no direct contact is made with the stone basket.Precautions: do not allow the device to come in contact with any electrical equipment.Do not rotate an open basket in the ureter.Potential complications that may result from the use of a basket in an endoscopic urological procedure include but are not limited to: perforation, edema, evulsion, entrapment, basket inversion, inability to disengage from, hemorrhage irretrievable object.Directions for use: only physicians trained in stone manipulation should perform this procedure.A variety of techniques in the use of this instrument may be employed; however, the physician should use the technique with which he/she is most familiar.Inspect the device prior to use and during the procedure.Retract instrument tip into sheath.In the closed position, insert the instrument into the ureteroscope working channel and advance the ureteroscope into the ureter or renal pelvis.With the basket closed/retracted, advance the instrument to the object to be removed.Push forward on thumb control knob to advance basket between object and ureteral wall.Once the object has been captured, partially close the basket to secure the object for removal.Simultaneously withdraw the basket and the ureteroscope from the urinary system.Handle disassembly/reassembly: if handle removal is desired: unscrew the thumb screw located on the basket handle.Gently pull backward on the handle, releasing both the handle and sheath from the drivewire/basket combination.If any resistance is felt at this stage, stop and determine cause of resistance.Once the stone burden within the basket has been removed, the basket can be closed using an open tip ureteral catheter.The basket can be reassembled easily by inserting the drivewire into the sheath and advancing until it reaches the handle.Tighten the thumb screw to secure the drivewire in place." (b)(4).

Event Description

It was reported that a part of the medical device was torn.The operator was obliged to remove it with a clamp and use an other medical device.

• Brand Name: BARD® PLATINUM CLASS¿ II FLAT WIRE STONE BASKET
• Type of Device: BARD FLATWIRE STONE BASKETS
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6954476
• MDR Text Key: 90345159
• Report Number: 1018233-2017-05308
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00801741066870
• UDI-Public: (01)00801741066870
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2021
• Device Model Number: 045290
• Device Catalogue Number: 045290
• Device Lot Number: BMASMM12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 64