MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION PLUS 7.5FR. FIBER OPTIC BALLOON CATHETER AND INSERTION KIT; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number	REF 0684-00-0568-01U
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Pt required balloon pump during case and the first balloon pump kit we opened did not inflate properly after placing into the patient.The co2 tubing was obstructed and not allowing the balloon to inflate.The balloon was removed from the patient and entire kit was removed from the field.A new balloon kit was opened and placed correctly into the patient.Fda safety report id# (b)(4).

• Brand Name: SENSATION PLUS 7.5FR. FIBER OPTIC BALLOON CATHETER AND INSERTION KIT
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; fairfield NJ 07004
• MDR Report Key: 14375408
• Report Number: MW5109651
• Device Sequence Number: 5653933
• Product Code: DSP
• UDI-Device Identifier: 10607567109565
• UDI-Public: (01)10607567109565
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/09/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/13/2024
• Device Catalogue Number: REF 0684-00-0568-01U
• Device Lot Number: 3000151487
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/11/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown