MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD UNKNOWN IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number UNKNOWN

Device Problem Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2019

Event Type  malfunction  

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)(4).

Event Description

It was reported that the patient was presented to the event site hospital due to old myocardial infarction (omi).Therapy was initiated using a cardiosave intra-aortic balloon pump (iabp) and intra-aortic balloon (iab) catheter.Subsequently, percutaneous coronary intervention (pci) was performed on the patient.On postoperative day three, an unspecified operation was performed on the patient and then on postoperative day six, the patient was reported to have moved strongly when a ventilator was attached to the patient.The arterial pressure waveform was noted to become unstable and temporarily spiky, however, the patient's condition was noted to remain stable and iabp therapy was completed.There was no reported injury to the patient.This report is for the 1st balloon used.

• Brand Name: UNKNOWN IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: dorota wolpiuk ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 9491183
• MDR Text Key: 189095266
• Report Number: 2248146-2019-00935
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 11/29/2019
• Initial Date FDA Received: 12/18/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1