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

Model Number 041900

Device Problems Accessory Incompatible (1004); Failure to Advance (2524)

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

Event Date 02/07/2019

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 during insertion of the basket, the user could not go through the working channel of the flexible ureteroscope. Additional information was received via email on 28 february 2019 from the international business center (ibc)representative. It was reported that during an intrarenal retrograde surgery, when passing the basket through the work channel, it did not advance.

Event Description

It was reported that during insertion of the basket, the user could not go through the working channel of the flexible ureteroscope. Additional information was received via email on 28 february 2019 from the international business center (ibc)representative. It was reported that during an intrarenal retrograde surgery, when passing the basket through the work channel, it did not advance.

Manufacturer Narrative

The reported event was confirmed. Visual evaluation of the returned sample noted one used skylite stone basket in opened original packaging. It was noted that there was kinking and an uneven surface with bumps and indentation 9 inches from the tip. It was possible that these defects had contributed to the inability to pass the stone basket through the scope. Deformations on the sheath are out of specification. It was noted that the stone basket opened and closed easily without issue. 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: "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".

• 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: 8424190
• Report Number: 1018233-2019-01337
• 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
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/30/2021
• Device Model Number: 041900
• Device Catalogue Number: 041900
• Device Lot Number: NGCW0366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No