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

Catalog Number 0684-00-0604

Device Problem No Device Output (1435)

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

Event Date 01/25/2019

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 an intra-aortic balloon (iab) was inserted on an ihd(ischaemic heart disease) patient, but during therapy, it was noted that the waveform was unable to be obtained.The customer obtained arterial pressure from transducer to continue procedure.No patient injury was reported.

Event Description

It was reported that an intra-aortic balloon (iab) was inserted on an ihd(ischaemic heart disease) patient, but during therapy, it was noted that the waveform was unable to be obtained.The customer obtained arterial pressure from transducer to continue procedure.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).

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.The extender tubing was also returned.The inner lumen was found to be occluded with dried blood.The occlusion was unable to be cleared.A sensor output test was performed and the sensor was found to be within specification.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and no leaks were detected.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), record # (b)(4).

Event Description

It was reported that an intra-aortic balloon (iab) was inserted on an ihd(ischaemic heart disease) patient, but during therapy, it was noted that the waveform was unable to be obtained.The customer obtained arterial pressure from transducer to continue procedure.No patient injury was reported.

• Brand Name: TRANS-RAY PLUS 7.5 FR. 35CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 8358418
• MDR Text Key: 137047666
• Report Number: 2248146-2019-00110
• 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

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2021
• Device Catalogue Number: 0684-00-0604
• Device Lot Number: 3000078602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Device Age: YR
• Date Manufacturer Received: 03/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1