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

Catalog Number 0684-00-0549-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bradycardia (1751)

Event Date 11/10/2020

Event Type  Injury  

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.Complaint record id # (b)(4).

Event Description

It was reported during use of cardiosave iabp that the alarm did not sound even though the drive was stopped frequently.Upon hearing the situation, the patient had bradycardia and the signal output from the bedside monitor, which is the signal output source was unstable, so the ecg signal to the iabp was unstable (with or without r wave).It was assumed that the iabp drive was temporarily stopped.There was no reported malfunction on the intra-aortic balloon(iab).A separate report will be submitted for the cardiosave iabp.

Manufacturer Narrative

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 sep-19 to nov-20 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint#: (b)(4).H3 other text: device not returned.

Event Description

N/a.

• Brand Name: YAMATO PLUS-R 7.5FR. 30CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 10937460
• MDR Text Key: 219307485
• Report Number: 2248146-2020-00640
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• 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: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0549-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARDIOSAVE.; CARDIOSAVE
• Patient Outcome(s): Other