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

Catalog Number 0684-00-0474

Device Problem Leak/Splash (1354)

Patient Problems Hematoma (1884); Pain (1994); Paresthesia (4421)

Event Date 03/23/2024

Event Type  Injury  

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 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.

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete an evaluation.Reference complaint (b)(4).

• Brand Name: LINEAR 7.5FR. 34CC IAB
• Type of Device: 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: 19139903
• MDR Text Key: 340561994
• Report Number: 2248146-2024-00238
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567109503
• UDI-Public: 10607567109503
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/13/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0474
• Device Lot Number: 3000333504
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 05/13/2024
• Supplement Dates FDA Received: 05/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/08/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Outcome(s): Required Intervention