MAUDE Adverse Event Report: DATASCOPE CORP. LINEAR 7.5FR. 40CC IAB WITH ACCESSORIES, US ONLY; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0480-01U
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Registered nurse (rn) monitoring patient with right femoral balloon pump in place.Machine alarmed that it was in standby, as well as for loss of gas.Rn assessed balloon tubing and found blood specks to be throughout the tubing.Clamped tubing immediately and notified provider of rupture.Patient had to undergo expedite procedure.

• Brand Name: LINEAR 7.5FR. 40CC IAB WITH ACCESSORIES, US ONLY
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 18967808
• Report Number: 18967808
• Device Sequence Number: 20386787
• Product Code: DSP
• UDI-Device Identifier: 10607567109527
• UDI-Public: (01)10607567109527
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2023
• Report Date (Section F): 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 0684-00-0480-01U
• Device Catalogue Number: 0684-00-0480-01U
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/22/2023