MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0470-01

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/24/2022

Event Type  Death  

Manufacturer Narrative

Event site postal code: (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).Device not returned.

Event Description

It was reported that the patient had open cardiac surgery with cardiopulmonary bypass (cpb).The patient needed a double mitral-aortic valve replacement due to endocarditis.It was noted that weaning off cpb was difficult and high drug support was required in the operating room (or) and while on cpb.Intra-aortic balloon (iab) therapy was initiated to help support the weaning.After insertion, a treatment by ecmo was performed of second-line in addition to iab therapy.The patient was then transferred to the intensive care unit (icu).After approximately two days of iab therapy, a leak occurred and blood was seen in the tubing.It was also noted that the console had generated an alarm.The iab was removed and replaced with a new one to continue therapy.Despite the support, the patient expired due to their condition of endocarditis and double valve replacement.This report of for the 2nd iab used.A separate report has been submitted for the 1st iab under mfg report number 2248146-2022-00234.

Manufacturer Narrative

Date of death updated.The device has not been returned to the manufacturer so we are unable to complete an evaluation.Analysis of production (3331/213) - the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis (4109/213) - the review of the historical data was performed.Trend analysis (4110/213) - the overall complaint trend data for the period (b)(6) through (b)(6) was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint #(b)(4).

Event Description

N/a.

• Brand Name: SENSATION 7FR. 40CC 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: 13891375
• MDR Text Key: 287835815
• Report Number: 2248146-2022-00236
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567106779
• UDI-Public: 10607567106779
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 05/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2024
• Device Model Number: 0684-00-0470-01
• Device Catalogue Number: 0684-00-0434
• Device Lot Number: 3000141744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/03/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Outcome(s): Death
• Patient Age: 71 YR
• Patient Weight: 83 KG