MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUTANEOUS ACCESS NEEDLE; CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number REF: M006700122

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/29/2021

Event Type  malfunction  

Event Description

Percutaneous access needle defective, stylet stuck so unable to use needle.No patient harm.New needle obtained.Fda safety report id# (b)(4).

• Brand Name: PERCUTANEOUS ACCESS NEEDLE
• Type of Device: CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 11608000
• MDR Text Key: 243809950
• Report Number: MW5100514
• Device Sequence Number: 1
• Product Code: GBO
• 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: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2022
• Device Model Number: REF: M006700122
• Device Lot Number: 22294848
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/01/2021
• 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