MAUDE Adverse Event Report: NULL DPFG; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number 65-68-130

Device Problem Defective Device (2588)

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

Event Date 08/08/2020

Event Type  malfunction  

Event Description

It was reported that the device unintentionally stopped during the use of it.No patient injury was reported.

Manufacturer Narrative

A device history record (dhr) review was conducted which indicated all inspection were completed and no issues were noted during manufacture.No investigation or root cause has been provided and the investigation could not be confirmed whether a quality related issue has resulted in the customer reported problem.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms # 617147.

• Brand Name: DPFG
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section G): NULL
• MDR Report Key: 15464075
• MDR Text Key: 306206627
• Report Number: 3012307300-2022-20085
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 65-68-130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1