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

Patient Problems Hematoma (1884); Pain (1994); Paralysis (1997)

Event Date 03/23/2024

Event Type  Injury  

Event Description

Blood was noted in left axillary intra-aortic balloon pump (iabp) helium sheath after patient turned onto her left side.Blood found in the balloon.Immediate pain and paresthesia to left lower extremity, vascular surgery consulted, patient went to the operating room for left axillary artery repair and hematoma removal.

• Brand Name: LINEAR 7.5FR. 34CC IAB WITH ACCESSORIES, US ONLY
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 15 law drive; fairfield NJ 07004
• MDR Report Key: 18989980
• MDR Text Key: 338761044
• Report Number: 18989980
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567109503
• UDI-Public: (01)10607567109503
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 0684-00-0479-01U
• Device Catalogue Number: 0684-00-0479-01U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/26/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/28/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening