MAUDE Adverse Event Report: BARD FLAT WIRE STONE BASKET; DISLODGER, STONE, BASKET

Model Number 045215

Device Problems Component Missing (2306); Device Or Device Fragments Location Unknown (2590)

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

Event Date 01/09/2018

Event Type  Injury  

Event Description

While using the flat wire stone basket, within a patient, the basket disappeared.An exhaustive search was undertaken to determine the location of the basket, however, it was not recovered.There is a chance that the basket retracted within the sheath of the device, however, that cannot be confirmed.

• Brand Name: FLAT WIRE STONE BASKET
• Type of Device: DISLODGER, STONE, BASKET
• Manufacturer (Section D): BARD ; crawley, west sussex, gb RH 11 9BP; UK RH 119BP
• MDR Report Key: 7193732
• MDR Text Key: 97497123
• Report Number: MW5074565
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 045215
• Device Catalogue Number: 045215
• Device Lot Number: BMAWMM10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 86 YR
• Patient Weight: 113