MAUDE Adverse Event Report: BAYER HEALTHCARE LLC SPIROFLEX; CATHETER, EMBOLECTOMY

Model Number 106553-001

Device Problems Defective Device (2588); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 04/26/2023

Event Type  malfunction  

Event Description

Angiojet spiroflex monorail catheter malfunctioned and found defective during stemi procedure.A replacement angiojet catheter was opened and successfully used without any complications or issues.

• Brand Name: SPIROFLEX
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BAYER HEALTHCARE LLC; 36 columbia rd; morristown NJ 07960
• MDR Report Key: 16960876
• MDR Text Key: 315548886
• Report Number: 16960876
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/02/2023

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 Model Number: 106553-001
• Device Catalogue Number: 106553
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/02/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/19/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27010 DA
• Patient Sex: Male