MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD MEGA 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0296-01

Device Problems Inability to Auto-Fill (1044); Inflation Problem (1310)

Patient Problem Ischemia (1942)

Event Date 05/22/2021

Event Type  Injury  

Manufacturer Narrative

Complete event site name: nasser institute for research and treatment the device will not be returned to the manufacturer so we are unable to complete an evaluation.Customer indicated that the device was not kept for evaluation.If additional information becomes available, we will send a supplemental report.Complaint record id # (b)(4).

Event Description

It was reported that during intra-balloon (iab) therapy, an auto-fill failure occurred and the iab would not inflate.This caused ischemia in the patient's leg and it is related to his general condition.The customer states that the complication was technical and due to how the surgeon inserted the iab.

Event Description

N/a.

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete an evaluation.Trend analysis (4110/213) - the overall complaint trend data for the period jun-2019 to may-202 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint (b)(4).

• Brand Name: MEGA 8FR. 50CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• MDR Report Key: 12048535
• MDR Text Key: 257712616
• Report Number: 2248146-2021-00403
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108001
• UDI-Public: 10607567108001
• Combination Product (y/n): N
• PMA/PMN Number: K091449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0684-00-0296-01
• Device Catalogue Number: 0684-00-0497
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/03/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR