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

Catalog Number 0684-00-0475

Device Problems Filling Problem (1233); Leak/Splash (1354); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/14/2019

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, the balloon had ruptured and blood was seen inside the balloon.The iab was in use nearly 12 hours before it was removed.After the balloon was removed, the doctor observed that the blood inside the balloon had crystallized.There was also an autofill failure alarm generated on the console.There was no reported injury to the patient.

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the balloon had ruptured and blood was seen inside the balloon.The iab was in use nearly 12 hours before it was removed.After the balloon was removed, the doctor observed that the blood inside the balloon had crystallized.There was also an autofill failure alarm generated on the console.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).

• Brand Name: LINEAR 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: 8583762
• MDR Text Key: 144713287
• Report Number: 2248146-2019-00409
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K041281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/11/2019

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: 07/10/2021
• Device Catalogue Number: 0684-00-0475
• Device Lot Number: 3000077104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2019
• Initial Date Manufacturer Received: 04/15/2019
• Initial Date FDA Received: 05/06/2019
• Supplement Dates Manufacturer Received: 05/17/2019
• Supplement Dates FDA Received: 06/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 60