MAUDE Adverse Event Report: DATASCOPE CORP SENSATION PLUS 8FR, 50CC FIBER OPTIC BALLOON PUMP; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0576

Device Problems Unintended Ejection (1234); Defective Device (2588)

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

Event Date 05/21/2021

Event Type  malfunction  

Event Description

During an insertion of an intra aortic balloon (iab) catheter, the balloon failed (leaking).The iab catheter was explanted and a new one was replaced.No adverse out come to patient.Product and packaging was not saved.

• Brand Name: SENSATION PLUS 8FR, 50CC FIBER OPTIC BALLOON PUMP
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP; 15 law drive; fairfield NJ 07004
• MDR Report Key: 11929507
• MDR Text Key: 254003967
• Report Number: 11929507
• Device Sequence Number: 1
• Product Code: DSP
• 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: 05/27/2021

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: No Information
• Device Model Number: 0684-00-0576
• Device Catalogue Number: 0684-00-0576
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/27/2021
• Date Report to Manufacturer: 06/03/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25915 DA