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

Catalog Number 0684-00-0605

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Myocardial Infarction (1969)

Event Date 01/27/2019

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.(b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy on an ami (acute myocardial infarction) patient, it was noted that waveform was more spiky than usual.The customer obtained arterial pressure from transducer to continue procedure.An alarm was generated, but the alarm type is unknown.No patient injury was reported.

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

It was reported that during intra-aortic balloon (iab) therapy on an ami (acute myocardial infarction) patient, it was noted that waveform was more spiky than usual.The customer obtained arterial pressure from transducer to continue procedure.An alarm was generated, but the alarm type is unknown.No patient injury was reported.

Event Description

It was reported that during intra-aortic balloon (iab) therapy on an ami (acute myocardial infarction) patient, it was noted that waveform was more spiky than usual.The customer obtained arterial pressure from transducer to continue procedure.An alarm was generated, but the alarm type is unknown.No patient injury was reported.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and blood on the exterior of the catheter and between the catheter and the sheath.The returned sheath was over the catheter but it was not a maquet product.No blood was observed inside the iab catheter.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.A sensor output test was performed and the sensor was found to be within specification.The iab was placed on the cs300 pump and pumped for two hours which represents one complete autofill cycle.The iab pumped normally and no alarm sounded from the pump.The reported events 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), record # (b)(4).

• Brand Name: TRANS-RAY PLUS 7.5 FR. 40CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 8355648
• MDR Text Key: 136756460
• Report Number: 2248146-2019-00108
• 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: 04/02/2019

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: 08/13/2021
• Device Catalogue Number: 0684-00-0605
• Device Lot Number: 3000078603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Device Age: YR
• Initial Date Manufacturer Received: 01/28/2019
• Initial Date FDA Received: 02/20/2019
• Supplement Dates Manufacturer Received: 02/25/2019; 03/28/2019
• Supplement Dates FDA Received: 03/19/2019; 04/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1