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

Model Number	0684-00-0479-01U
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994); Paresthesia (4421)
Date of Event	03/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation: rn, mba, clinical value analyst.Additional reporter name: (b)(6) patient safety specialist, (b)(6).(b)(6) patient safety lead, (b)(6).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 that after two to three days of intra-aortic balloon (iab) therapy, blood was noted in the iab after the patient turned onto her left side when returned to supine position.The insertion was reported to be axillary, which is not the method described in the device instructions for use.The patient experienced immediate pain and paresthesia to left lower extremity.Vascular surgery was consulted and the patient went to the operating room for left axillary artery repair and hematoma removal.
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
**udi related data quality updates only** providing updated device identification information in alignment with gudid (d1, d2, d3, d4, g4, h4, h5).Complaint record id # (b)(4).
Event or Problem Description
N/a.

• Brand Name: LINEAR 7.5FR. 34CC IAB WITH ACCESSORIES, US ONLY
• 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: 19139903
• Report Number: 2248146-2024-00238
• Device Sequence Number: 15798738
• Product Code: DSP
• UDI-Device Identifier: 10607567109503
• UDI-Public: 10607567109503
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K041281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/08/2026
• Device Model Number: 0684-00-0479-01U
• Device Catalogue Number: 0684-00-0479-01U
• Device Lot Number: 3000333504
• 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: 03/28/2024
• Supplement Date Received by Manufacturer: 05/13/2024; 12/18/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 05/13/2024; 12/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/08/2023
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown