MAUDE Adverse Event Report: DATASCOPE MAHWAH UNKNOWN; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Discomfort (2330)

Event Date 09/25/2015

Event Type  Injury  

Manufacturer Narrative

The patient outcome was very good.He underwent a complete revascularization and he was discharged home.The dissection was managed without any intervention.The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not reviewed per company standard operating procedure since the serial number was not provided.Additional information was requested from the doctor who wrote the article, but no further information was provided.The doctor did advise there were no additional details of the events to be provided.Additional information has been requested from the customer, and will be reported if made available to us.

Event Description

A company representative reported reading an article which stated that an adverse event occurred on a patient due to the intra-aortic balloon pump (iabp).Angiography revealed severe triple vessel disease, left main coronary artery stenosis, and severe left ventricular systolic dysfunction on ventriculography.Due to continued chest discomfort and hemodynamic instability insertion of the intra-aortic balloon (iab) via the right femoral artery with fluoroscopy was done.A retrograde type b aortic dissection was caused by the intra-aortic balloon counterpulsation through the right femoral artery.A balloon complaint was opened in regards to this article, as well mfg report number 2248146-2017-00204.

• Brand Name: UNKNOWN
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd.; mahwah, NJ 07430
• MDR Report Key: 6802940
• MDR Text Key: 82981960
• Report Number: 2249723-2017-00307
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/17/2017

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 07/27/2017
• Initial Date FDA Received: 08/17/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 72 YR