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

Model Number	0684-00-0568-01
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during intra-aortic balloon (iab) therapy, a fiber optic sensor failure occurred.A new iab was inserted to continue therapy without further issue.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
Occupation - non-healthcare professional, rt(r) inventory specialist.Additional reporter: (b)(6).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.Complaint record id # (b)(4).
Additional Manufacturer Narrative
Device evaluation: the product was returned with the membrane completely unfolded and blood on the exterior of the catheter.Two kinks were found on the catheter tubing and inner lumen approximately 74.9cm and 76.2cm from the iab tip.Additionally the optical fiber was found to be broken within the membrane approximately 20.1cm from iab tip.The optical fiber was found to be broken, confirming the reported problem.We are unable to determine when this may have occurred.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Reference complaint #(b)(4).
Event or Problem Description
It was reported that immediately after initiating intra-aortic balloon (iab) therapy, a fiber optic sensor failure occurred.A new iab was inserted to continue therapy without further issue.There was no patient harm or adverse event reported.

• Brand Name: SENSATION PLUS 8FR. 50CC IAB
• Common Device Name: 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: 15192792
• Report Number: 2248146-2022-00608
• Device Sequence Number: 20219384
• Product Code: DSP
• UDI-Device Identifier: 10607567109435
• UDI-Public: 10607567109435
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K112327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/13/2025
• Device Model Number: 0684-00-0568-01
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000228181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2022
• Supplement Date Received by Manufacturer: 10/24/2022
• Initial Report FDA Received Date: 08/09/2022
• Supplement Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Sex: Male
• Patient Weight: 86 KG