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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® SKYLITE¿ TIPLESS NITINOL STONE BASKET; SKYLITE BASKET
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C.R. BARD, INC. (COVINGTON) -1018233 BARD® SKYLITE¿ TIPLESS NITINOL STONE BASKET; SKYLITE BASKET Back to Search Results
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".
 
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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 Key8424190
MDR Text Key139057423
Report Number1018233-2019-01337
Device Sequence Number1
Product Code FFL
UDI-Device Identifier00801741111518
UDI-Public(01)00801741111518
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
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 Received03/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2021
Device Model Number041900
Device Catalogue Number041900
Device Lot NumberNGCW0366
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/03/2019
Date Manufacturer Received05/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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