MAUDE Adverse Event Report: DATASCOPE FAIRFIELD YAMATO PLUS-R 7.5FR. 40CC IAB - JAPAN; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0549-03

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/21/2017

Event Type  malfunction  

Manufacturer Narrative

The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.(b)(4).

Event Description

On (b)(6) 2017, the intra-aortic balloon (iab) catheter was inserted in the patient in the femoral artery.On (b)(6) 2017, there was a ¿blood detected¿ alarm generated during use on a patient.The procedure was completed with replacement of the iab catheter.There was evidence of aortic calcification.No patient injury was reported.

Manufacturer Narrative

The iab was returned with the membrane completely unfolded.No blood was visible on the catheter.The extension tube was also returned.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal and extension tubing was performed and no leaks were detected.The iab was placed on the cs300 pump and pumped for two hours which represents one complete auto fill cycle.The iab pumped normally and no alarm sounded from the pump.The reported event cannot be confirmed by the evaluation.A device and lot history record review was completed for the reported product.No non-conformances were found that are considered to be related to the event.Complaint # (b)(4).

Event Description

On (b)(6) 2017, the intra-aortic balloon (iab) catheter was inserted in the patient in the femoral artery.On (b)(6) 2017, there was a ¿blood detected¿ alarm generated during use on a patient.The procedure was completed with replacement of the iab catheter.There was evidence of aortic calcification.No patient injury was reported.

• Brand Name: YAMATO PLUS-R 7.5FR. 40CC IAB - JAPAN
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 7132744
• MDR Text Key: 95811864
• Report Number: 2248146-2017-00724
• 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,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/06/2018

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: 03/29/2019
• Device Catalogue Number: 0684-00-0549-03
• Device Lot Number: 3000026983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Initial Date Manufacturer Received: 11/24/2017
• Initial Date FDA Received: 12/19/2017
• Supplement Dates Manufacturer Received: 01/15/2018
• Supplement Dates FDA Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 53