MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION 7FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0469-01
Medical Device Problem Codes	Difficult to Insert (1316); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that intra aortic balloon had an issue, unable to pass the guidewire through balloon.The hospital staff utilized another balloon and the same guidewire passed through it.There was no patient death or injury.
Additional Manufacturer Narrative
The device has not been returned to the manufacture yet, so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Comlaint record id # (b)(4).
Additional Manufacturer Narrative
Updated fields: e1 (event site email), g1 (contact person ¿ mfg site), h6 (type of investigation, investigation conclusions, investigation findings).The product was returned with the membrane completely unfolded and traces of blood was found inside of the inner lumen.The one-way valve was returned separate from the iab.-the engineer attempted to insert the laboratory 0.018in guidewire through the inner lumen and was able to successfully insert the guide wire.No obstructions were felt.-the one-way valve was vacuum tested, and it held vacuum.The reported difficult/unable to advance iab through guidewire cannot be confirmed by the evaluation.Per ifu the one-way valve must be aspirated to 30cc while leaving the one-way valve in place attached to the extracorporeal tubing leur to ensure vacuum is maintained throughout insertion.A lot history record review was completed for the reported product.No nonconformances were found that are related to the event.Complaint record id no.: (b)(4).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Corrected fields: d4- expiry date, d4-udi number, h4-mfg date.Updated fields: b4, g1-contact person at mfg site , g3, g6, h2, h11.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.Corrected fields: g4.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h11, corrected fields: h6 (medical device ¿ problem code).

• Brand Name: SENSATION 7FR. 34CC 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: 21156132
• Report Number: 2248146-2025-0000027
• Device Sequence Number: 7595682
• Product Code: DSP
• UDI-Device Identifier: 10607567106755
• UDI-Public: (01)10607567106755(10)3000309706(17)260502(11)230502
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/08/2025

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: 05/02/2026
• Device Model Number: 0684-00-0469-01
• Device Catalogue Number: 0684-00-0469-01
• Device Lot Number: 3000309706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2024
• Supplement Date Received by Manufacturer: 02/03/2025; 08/06/2025; 08/14/2025; 09/08/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 02/12/2025; 08/06/2025; 08/14/2025; 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2023
• 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: ANOTHER BALLOON
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 83 KG