MAUDE Adverse Event Report: COOK INCORPORATED TRANSSEPTAL NEEDLE; TROCAR

Model Number G02364

Device Problems Particulates (1451); Scratched Material (3020)

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

Event Date 11/24/2020

Event Type  malfunction  

Event Description

Needles consistently score the inside of the preface sheaths causing plastic shavings to come out when flushing the sheath.This has been ongoing and stock was sent back previously and replaced.But ep no longer wants to use this item unless the issues are fixed.No harm to patients.Manufacturer response for transseptal needle, (brand not provided) (per site reporter).Waiting for response from rep.

• Brand Name: TRANSSEPTAL NEEDLE
• Type of Device: TROCAR
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11214188
• MDR Text Key: 228171598
• Report Number: 11214188
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G02364
• Device Catalogue Number: G02364
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/21/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1