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 Problems Defective Device (2588); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 10/07/2019

Event Type  malfunction  

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.Complaint record # (b)(4).

Event Description

The customer reported receiving the product carton was received damaged.

Event Description

The customer reported receiving the product carton damaged.There was no reported patient involvement.

Manufacturer Narrative

Corrected sections: "describe event or problem" 'the customer reported receiving the product carton damaged.There was no reported patient involvement.' "health professional?" should be blank.Answer is unknown.Serial: (b)(4).Lot: 3000099577.Event site email: (b)(6).The iab carton was returned sealed and unused.It was observed to have physical damage in the upper & lower right-hand sections of the carton.The evaluation confirms the reported problem.We are unable to determine when this may have occurred.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.Complaint record # (b)(4).

• 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: 9217644
• MDR Text Key: 190386303
• Report Number: 2248146-2019-00845
• 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: 11/27/2019

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: 06/26/2022
• Device Catalogue Number: 0684-00-0567
• Device Lot Number: 3000099577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/07/2019
• Initial Date FDA Received: 10/22/2019
• Supplement Dates Manufacturer Received: 11/26/2019
• Supplement Dates FDA Received: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1