MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0575

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2020

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 the customer opened the intra-aortic balloon catheter kit and a part was missing.The customer set the product aside and opened another one to complete the case.There was no reported injury to the patient.

Event Description

It was reported the customer opened the intra-aortic balloon catheter kit and a part was missing.The customer set the product aside and opened another one to complete the case.There was no reported injury to the patient.

Manufacturer Narrative

Section h - device evaluation method code added: analysis of data provided by user/third party; 4112.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.Reference complaint #(b)(4).

• Brand Name: SENSATION PLUS 8FR. 50CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 10057676
• MDR Text Key: 195267455
• Report Number: 2248146-2020-00253
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K112327
• 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: 06/26/2020

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: 05/23/2022
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000096945
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/30/2020
• Initial Date FDA Received: 05/14/2020
• Supplement Dates Manufacturer Received: 06/26/2020
• Supplement Dates FDA Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 130