MAUDE Adverse Event Report: DATASCOPE CORP. LINEAR 7.5FR. 25CC IAB (WITH APA); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0478-02
Medical Device Problem Codes	Inappropriate Waveform (2536); Gas/Air Leak (2946); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during intra-aortic balloon (iab) therapy, a "gas loss" alarm had been happening for over an hour.The customer could resume pumping but within 1-2 minutes the alarm would happen again.The insertion was reported to be axillary, which is not the method described in the device instructions for use.They had ordered a chest film for placement location.There was no blood or visible kink in the helium tubing.The getinge representative offered troubleshooting suggestions as if the iab were placed via femoral artery.They were unsuccessful in resolving the alarm.The iab status bar did not fill fully, and the iab pressure waveform looked rounded, indicating a likely kink in the catheter.The icu nurse practitioner was contacted and spoke with the physician about further steps.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
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).
Additional Manufacturer Narrative
Providing updated device identification information in alignment with gudid.Complaint record id # (b)(4).

• Brand Name: LINEAR 7.5FR. 25CC IAB (WITH APA)
• 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: jingal amin ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 20022160
• Report Number: 2248146-2024-00502
• Device Sequence Number: 17975825
• Product Code: DSP
• UDI-Device Identifier: 10607567106533
• UDI-Public: (01)10607567106533(10)3000331566(17)260811(11)230811
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K041281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/19/2024

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: 08/11/2026
• Device Model Number: 0684-00-0478-02
• Device Catalogue Number: 0684-00-0478-02
• Device Lot Number: 3000331566
• 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: 07/31/2024
• Supplement Date Received by Manufacturer: 09/13/2024; 11/19/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 09/13/2024; 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 59 KG