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

Catalog Number 0684-00-0567

Device Problems Unraveled Material (1664); Malposition of Device (2616)

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

Event Date 05/18/2018

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 that the iab unwrapped prior to insertion and seemed to jump in the aorta during inflation.The indication for use is left main disease 99%.There was no reported injury to the patient.

Event Description

It was reported that during intra-aortic balloon (iab) therapy that the iab unwrapped prior to insertion and seemed to jump in the aorta during inflation.The indication for use is left main disease 99%.There was no reported injury to the patient.

Manufacturer Narrative

No decontamination or visual inspection of product was performed since it was not returned.A video was provided for this event which shows the iab movement.A review of the video confirms the reported iab migration/movement.A visual review of the video is unable to confirm difficulty during insertion of the iab.The product was not returned and so could not be evaluated for root cause.A review of the provided video confirms the iab migration event, but we are unable to confirm the difficulty during insertion of the iab based on the provided video.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.(b)(4).

• Brand Name: SENSATION PLUS 7.5FR. 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: 7587674
• MDR Text Key: 111147538
• Report Number: 2248146-2018-00375
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K122628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2021
• Device Catalogue Number: 0684-00-0567
• Device Lot Number: 3000068053
• Was Device Available for Evaluation?: No
• Device Age: YR
• Date Manufacturer Received: 06/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 93