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

Catalog Number 0684-00-0605

Device Problems Device Alarm System (1012); Optical Problem (3001)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/08/2019

Event Type  malfunction  

Manufacturer Narrative

Complete event site name - (b)(6) center.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 in an acute myocardial infarction (ami) patient, there was a iab optical sensor failure alarm on the console.Few days later, the iab was removed and customer discontinued iabp therapy.There was no reported injury to the patient.

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 in an acute myocardial infarction (ami) patient, there was a iab optical sensor failure alarm on the console.Few days later, the iab was removed and customer discontinued iabp therapy.There was no reported injury to the patient.

Manufacturer Narrative

The product was returned with the membrane completely unfolded with blood on the exterior of the catheter.Four kinks were found on the catheter tubing approximately 20.3, 28.7, 29.2 & 76.2cm from the iab tip.Additionally, the optical fiber was found to be broken within the membrane.The optical fiber was found to be broken, confirming the reported alarm.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.Reference complaint #ca-cpl-2019-00997; record id (b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy in an acute myocardial infarction (ami) patient, there was a iab optical sensor failure alarm on the console.Few days later, the iab was removed and customer discontinued iabp therapy.There was no reported injury to the patient.

• Brand Name: TRANS-RAY PLUS 7.5 FR. 40CC 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: 8555196
• MDR Text Key: 143585937
• Report Number: 2248146-2019-00381
• 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: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2021
• Device Catalogue Number: 0684-00-0605
• Device Lot Number: 3000081527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Device Age: YR
• Date Manufacturer Received: 07/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 75