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

Model Number 045370

Device Problems Entrapment of Device (1212); Material Rupture (1546); Device Inoperable (1663); Positioning Problem (3009)

Patient Problems Rupture (2208); No Known Impact Or Consequence To Patient (2692)

Event Date 04/22/2018

Event Type  Injury  

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.

Event Description

It was reported that during the removal of a stone, the basket would not close around the stone and got stuck in the urethra.The nurse stated that the basket ruptured the ureter and the patient required additional surgery and had a stent placed.Per additional information received from complainant.The additional surgery was immediately performed.There were no additional complications.It is unknown the size of the stone.

Event Description

It was reported that during the removal of a stone, the basket would not close around the stone and got stuck in the urethra.The nurse stated that the basket ruptured the ureter and the patient required additional surgery and had a stent placed.It was later reported that additional surgery was immediately performed.There were no additional complications.It is unknown the size of the stone.

Manufacturer Narrative

The reported event is confirmed.However, the root cause is unknown.While intact, basket wires were twisted and elongated.The tip of the basket showed evidence of burn marks.Under 10x magnification the tip of the basket showed either tissue or burn marks.Inspection of the basket noted that the basket was able to open and close, however, not inside the sheath as the sheath was missing.Per evaluation performed at the supplier facility, the issues observed occurred post manufacturing.The basket performed according to specification.Based on the investigation findings, current manufacturing controls are considered adequate as to detect and segregate any nonconforming unit.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.".

• Brand Name: BARD® PLATINUM CLASS¿ II FLAT WIRE STONE BASKET
• Type of Device: STONE BASKET
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7511127
• MDR Text Key: 108160845
• Report Number: 1018233-2018-01692
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00801741066894
• UDI-Public: (01)00801741066894
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 045370
• Device Catalogue Number: 045370
• Device Lot Number: BMAWMM12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2018
• Date Manufacturer Received: 06/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention