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

Model Number 041900

Device Problem Break (1069)

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

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 skylite basket had an unspecified malfunction.Per additional information received from the complainant via email on (b)(6) 2019 the hand piece of the device was broken.

Manufacturer Narrative

The reported event was confirmed.The device did not meet specifications.The product was used for treatment purposes.The product was influenced by the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used skylite nitinol basket.Visual inspection of the sample noted the green basket slide was detached.This is our of specification per inspection procedure , revision, which states, "assembly pattern must comply with drawing and visual aid." both drawing and visual aid , showed the green basket slide inserted into the basket handle subassembly and completely attached.The lower basket handle was removed, the green basket slide was reinserted into the handle subassembly (basket and sheath, slide cover, thumb screw, washer, and bolt), and the lower basket handle was reattached.Once the subassembly was reassembled, the basket functioned normally.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be, ¿material selection.¿ 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: ¿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." 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.

Event Description

It was reported that the skylite basket had an unspecified malfunction.Per additional information received from the complainant via email on jul 29 2019 the hand piece of the device was broken.

• Brand Name: BARD® SKYLITE¿ TIPLESS NITINOL STONE BASKET
• Type of Device: SKYLITE BASKET
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8892422
• MDR Text Key: 161775571
• Report Number: 1018233-2019-04703
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 041900
• Device Catalogue Number: 041900
• Device Lot Number: NGDN1712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Date Manufacturer Received: 08/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1