MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0469-01

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2022

Event Type  malfunction  

Manufacturer Narrative

Occupation - non-healthcare professional (cath lab materials coordinator).Additional reporter: (b)(6).The device was not returned and could not be evaluated.It was discarded by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.Complaint record id # (b)(4).

Event Description

It was reported that when opening the intra-aortic balloon (iab) packaging, it was missing the stopcock.The part was taken from another package to initiate therapy.There was no patient harm or adverse event reported.

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete an evaluation.Reference complaint #(b)(4).

• Brand Name: SENSATION 7FR. 34CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ
• MDR Report Key: 16015205
• MDR Text Key: 308242365
• Report Number: 2248146-2022-00992
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2023
• Device Model Number: 0684-00-0469-01
• Device Catalogue Number: 0684-00-0433
• Device Lot Number: 3000133100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1