MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ARTICULATING STONE BASKET

Catalog Number 043313

Device Problem Material Frayed (1262)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental reported 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 extraction of the device from ureteroscope, the central basket went inside the outer sheath giving the impression that the tip of the basket had been lost in the patient.As a precaution, the patient's renal/urinary system was fully visually inspected, washed out, then inspected via a image intensifier unit and no fragments were found.Ct was planned for a more detailed inspection.The patient received a slightly higher dose of irradiation due to the search of the renal system.Duty of candor followed by surgeon when patient was awake.Unit was inspected by complainant on (b)(6) 2015; basket was found to be intact but had been withdrawn fully into outer sheath giving the impression of a lost part of the basket (please see attached photograph - damaged unit has a frayed outer sheath because complainant had to physically strip it back to reveal the basket tip - other unit for comparison only).Relevant staff and the patient was informed.

Manufacturer Narrative

Received 1 used stone basket with the original unit labeling.Visual inspection noted that the drive wires had broken proximal to the basket and had broken through the sheath.Further inspection noted that the sheath was extremely damaged/frayed at the distal end near the basket.The broken drive wires were most likely caused by the user when stripping back the sheath because the basket would not have been able to withdraw into the sheath if the drive wires had broken during the procedure.The basket would have been immobile.The breakage of the stone basket occurred post procedure and was possibly caused by excessive force used during evaluation by the complainant.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The complaint was unconfirmed as the problem could not be reproduced.The instructions for use state the following: description: the bard® dimension® stone basket is a teardrop-shaped basket with the ability to capture stones by: simply opening and closing the basket and articulating or moving the basket side to side.The device consists of 3 main parts: 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 bard® dimension® stone 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 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 to injury, illness or death of the patient.Caution: 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 allow the device to be directly fired upon by any lithotripsy device.To do so may damage 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, 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.Inspect the device prior to use and during the procedure.Make sure the basket is closed by retracting the basket-tip into the sheath with the thumb slide (a).Insert the basket into the ureteroscope working-channel and advance the ureteroscope to the object to be removed.Under direct vision or fluoroscopic guidance, slowly advance the tip of the stone basket past the object.Conventional use: open the basket with the thumb slide (a).Pull the basket backward toward the object while slowly rotating the basket.Once the object has been captured, partially close the basket to secure the object for removal by pulling the thumb slide (a) back.Simultaneously, withdraw the basket and the ureteroscope from the urinary system.Articulating use: use the control wheel (b) to articulate the basket by moving the wheel forward or backward.Articulate the basket as needed to capture the object.Once the object has been captured, partially close the basket to secure the object for removal by pulling the thumb slide (a) back.Simultaneously, withdraw the basket and the ureteroscope from the urinary system." (b)(4).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.

• Brand Name: ARTICULATING STONE BASKET
• Type of Device: STONE BASKET
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd.; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON); 8195 industrial blvd.; covington GA 30014
• Manufacturer Contact: janna parks ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 5020166
• MDR Text Key: 23662084
• Report Number: 1018233-2015-00309
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 02/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 043313
• Device Lot Number: BMYAM023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2014
• 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 Outcome(s): Required Intervention