MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD MEGA 7.5FR. 30CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0294-01
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802)
Date of Event	02/14/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
(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.(b)(4).
Event or Problem Description
It was reported that the patient was taken to cardiac theatre for emergency surgery.Patient arrested in operating theatre prior to the commencement of surgery.During a prolonged resuscitation process the physicians attempted the insertion of three intra-aortic balloon(iab) catheters.Resuscitation was unsuccessful and the patient subsequently died.The cause of death was stated as pulmonary artery tear.The notes also said there was an aortic rupture complicated from iab insertion and iab catheter rupture.The customer said they did not believe the iab insertion had contributed to the patients unfortunate death.This report is for the 1st iab used.A separate report will be submitted for the 2nd and 3rd iab.
Event or Problem Description
It was reported that the patient was taken to cardiac theatre for emergency surgery.Patient arrested in operating theatre prior to the commencement of surgery.During a prolonged resuscitation process the physicians attempted the insertion of three intra-aortic balloon(iab) catheters.Resuscitation was unsuccessful and the patient subsequently died.The cause of death was stated as pulmonary artery tear.The notes also said there was an aortic rupture complicated from iab insertion and iab catheter rupture.The customer said they did not believe the iab insertion had contributed to the patients unfortunate death.This report is for the 1st iab used.A separate report will be submitted for the 2nd and 3rd iab.
Additional 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.Reference complaint#: (b)(4).H3 other text: device not returned.

• Brand Name: MEGA 7.5FR. 30CC IAB
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 11375863
• Report Number: 2248146-2021-00136
• Device Sequence Number: 19798192
• Product Code: DSP
• UDI-Device Identifier: 10607567107950
• UDI-Public: 10607567107950
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K120868
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2021

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
• Operator of Device: Health Professional
• Device Model Number: 0684-00-0294-01
• Device Catalogue Number: 0684-00-0292
• Device Lot Number: 300005308
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 87 YR
• Patient Weight: 59