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

Model Number	0684-00-0479-01
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2023
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)(6).
Event or Problem Description
It was reported that during intra-aortic balloon (iab) therapy, the customer called on (b)(6) 2023 at 8:22am stating there was possibly blood in the helium tubing.They noted that there was a brown substance in the helium tubing near the white ¿y¿ fitting.They also noted that there was one alarm a couple hours prior to noticing the substance.There had not been any alarms since and no interruption to therapy.The getinge representative reviewed the customer's options with them.They planned to contact the attending physician to find out if removal or removal and replacement would be performed.The iab had been inserted since (b)(6) 2023 and there had not been any prior issues.There was no patient harm or adverse event reported.
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
It was reported that during intra-aortic balloon (iab) therapy, the customer called on (b)(6) 2023 at 8:22am stating there was possibly blood in the helium tubing.They noted that there was a brown substance in the helium tubing near the white ¿y¿ fitting.They also noted that there was one alarm a couple hours prior to noticing the substance.On (b)(6) 2023.At 6:35am, and rn noted that "blood in helium tubing." there had not been any alarms since and no interruption to therapy.One member of the hospital staff stated that the "device overheated and placed itself in standy without any preceding alarms." the getinge representative reviewed the customer's options with them.They planned to contact the attending physician to find out if removal or removal and replacement would be performed.The iab had been inserted since (b)(6) 2023 and there had not been any prior issues.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
Udi related data quality updates only: providing updated device identification information in alignment with gudid.Reference complaint # (b)(4).
Event or Problem Description
N/a.

• Brand Name: LINEAR 7.5FR. 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: brian schaeffer ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 18498438
• Report Number: 2248146-2024-00027
• Device Sequence Number: 20799366
• Product Code: DSP
• UDI-Device Identifier: 10607567106557
• UDI-Public: (01)10607567106557(10)3000313719(17)260601(11)230601
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 10/11/2024

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: 06/01/2026
• Device Model Number: 0684-00-0479-01
• Device Catalogue Number: 0684-00-0479-01
• Device Lot Number: 3000313719
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2023
• Supplement Date Received by Manufacturer: 02/28/2024; 10/11/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 02/29/2024; 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2023
• 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: UNKNOWN.
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 71 KG