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

Catalog Number 0684-00-0567

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

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.Complaint record id # (b)(4).

Event Description

It was reported that prior to use, during the pre-use device inspection, it was noted that the expiration date appeared to be prior to the manufacturing date.There was no reported patient involvement since this occurred prior to use.

Manufacturer Narrative

A visual inspection of the returned product determined that the labeling was incorrect.The evaluation confirms that the outside label on the shelf carton had the expiration date prior to the manufacturing date.A device and 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).

Event Description

It was reported that prior to use, during the pre-use device inspection, it was noted that the expiration date appeared to be prior to the manufacturing date.There was no reported patient involvement since this occurred prior to use.

• Brand Name: SENSATION PLUS 7.5FR. 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: 8823925
• MDR Text Key: 186143623
• Report Number: 2248146-2019-00626
• 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,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2021
• Device Catalogue Number: 0684-00-0567
• Device Lot Number: 3000079459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2248146-05/22/2019-002-R
• Patient Sequence Number: 1