MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0479-02
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient with decompensated heart failure and a history of heart transplantation in 2019 was in need of urgent intra-aortic balloon (iab) therapy.The iab was inserted without improvement in blood pressure.The console generated a gas loss in iab circuit alarm and blood was seen entering the iab catheter.The iab was removed and replaced with a new one to continue therapy without further issue.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
Event site postal code: (b)(6).The device was not returned and could not be evaluated.It was discarded by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.Complaint record id # (b)(4).
Additional Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation.Reference complaint #(b)(4).
Event or Problem Description
N/a.

• Brand Name: LINEAR 7.5 FR. 34CC IAB
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ
• MDR Report Key: 16371284
• Report Number: 2248146-2023-00100
• Device Sequence Number: 17869563
• Product Code: DSP
• UDI-Device Identifier: 10607567106540
• UDI-Public: 10607567106540
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K041281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2023

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: 04/05/2025
• Device Model Number: 0684-00-0479-02
• Device Catalogue Number: 0684-00-0474
• Device Lot Number: 3000233186
• 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: 01/23/2023
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/06/2022
• 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: UNKNOWN.
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 36 KG