MAUDE Adverse Event Report: BARD BARD PLATINUM STONE BASKET

Catalog Number 045215

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2016

Event Type  malfunction  

Event Description

Piece of the stone basket broke off in pt's ureter.Doctor was able to retrieve the broken part of the basket."there damage to pt.".

• Brand Name: BARD PLATINUM STONE BASKET
• Type of Device: STONE BASKET
• Manufacturer (Section D): BARD; covington GA 30014
• MDR Report Key: 6053546
• MDR Text Key: 58426368
• Report Number: MW5065564
• Device Sequence Number: 1
• Product Code: FAD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 045215
• Device Lot Number: BMZHM025
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/21/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26 YR