MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP. ZERO TIP NITINOL STONE RETRIEVAL BASKET; DISLODGER, STONE, BASKET, URETERAL, METAL

Catalog Number M00063901030

Device Problems Therapeutic or Diagnostic Output Failure (3023); Physical Resistance/Sticking (4012)

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

Event Date 10/25/2019

Event Type  malfunction  

Event Description

Nitinol stone retrieval basket malfunctioned.According to md "the wire is stuck at the opening of the channel and will not work" during procedure.Fda safety report id# (b)(4).

• Brand Name: ZERO TIP NITINOL STONE RETRIEVAL BASKET
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORP.
• MDR Report Key: 9271560
• MDR Text Key: 165110897
• Report Number: MW5090836
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: M00063901030
• Device Lot Number: 23724425
• 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 Age: 35 YR
• Patient Weight: 95