MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD YAMATO PLUS-R 7.5FR. 35CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0549-02

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2019

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 after insertion of the intra-aortic balloon (iab) and start of therapy, the console generated a check iab catheter (flow restriction) alarm.The balloon was replaced to start therapy.There was no reported injury to the patient.

Manufacturer Narrative

Additional information: section h - evaluation method codes.Analysis of production records; 3331.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).Mdr originally submitted on october 9, 2019.Resubmitted per cdrh request from: esg help desk (b)(6) on 10/10/2019, at 4:47 pm, (b)(6) wrote: "hello, we were notified that cdrh processing system had intermittent issues processing submissions ("adverse_events" and "electronic submissions" ) from 1pm est on october 9, 2019 to 2pm est on october 10, 2019.Cdrh has requested users to resend submissions if you have not received ack3 or ack4 for your submissions sent during this time.

Event Description

It was reported after insertion of the intra-aortic balloon (iab) and start of therapy, the console generated a check iab catheter (flow restriction) alarm.The balloon was replaced to start therapy.There was no reported injury to the patient.

Manufacturer Narrative

Section d.Suspect medical device: changed lot number from 3000092778 to 3000079504.

Event Description

It was reported after insertion of the intra-aortic balloon (iab) and start of therapy, the console generated a check iab catheter (flow restriction) alarm.The balloon was replaced to start therapy.There was no reported injury to the patient.

• Brand Name: YAMATO PLUS-R 7.5FR. 35CC 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: 9080257
• MDR Text Key: 189305794
• Report Number: 2248146-2019-00752
• 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,Followup
• Report Date: 10/11/2019

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 Expiration Date: 07/25/2021
• Device Catalogue Number: 0684-00-0549-02
• Device Lot Number: 3000079504
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/28/2019
• Initial Date FDA Received: 09/18/2019
• Supplement Dates Manufacturer Received: 10/09/2019; 10/11/2019
• Supplement Dates FDA Received: 10/10/2019; 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1