MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION 7FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0470-01
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id (b)(4).
Event or Problem Description
It was reported by the customer that during use the intra-aortic balloon (iab) when the intensive care physician inserted the counterpulsation balloon, blood return was evident across the entire surface, leading to the conclusion that the balloon was ruptured.There was no patient harm or injury reported.
Additional Manufacturer Narrative
After further review it was determined that the complaint was already reported in tw#: (b)(4).Hence, the record is invalid as it is a duplicate.Please cancel in your database.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields b4, g3, g6, h2, h6, type of investigation, investigation findings, investigation conclusions, h11.Corrected field e1 event site name.An intra aortic balloon iab leak is the loss of integrity in the balloon membrane or its connections allowing blood or gas to enter or escape.Since the product was not returned and based on the limited details provided by the user the exact cause of this particular event was not able to be identified.However causes of iab leaks can include one or more of the following: 1.User not following instructions per ifu mishandling, 2.Misuse of device, 3.Membrane folding resistance, 4.Patient related factors such as plaque abrasion.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Correction to h11: after further review it was determined that the event was already reported in mfg report no: 2248146-2026-0000630.Please refer to mfg report no: 2248146-2026-0000630 for all event related information.Please cancel mfg report no: 2248146-2026-0000707 in your database.
Event or Problem Description
N/a.

• Brand Name: SENSATION 7FR. 40CC IAB
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE CORP.; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: ewelina chorlowska ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 24375670
• Report Number: 2248146-2026-0000707
• Device Sequence Number: 17538699
• Product Code: DSP
• UDI-Device Identifier: 10607567106779
• UDI-Public: (01)10607567106779(10)3000475243(17)280515(11)250515
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/31/2026

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 Model Number: 0684-00-0470-01
• Device Catalogue Number: 0684-00-0470-01
• Device Lot Number: 3000475243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 03/13/2026; 03/27/2026; 03/31/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 03/13/2026; 03/30/2026; 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IABP.
• Patient Age: 77 YR
• Patient Sex: Male