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

Model Number 0684-00-0576-01

Device Problem Pressure Problem (3012)

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

Event Date 04/20/2023

Event Type  malfunction  

Event Description

It was reported that the intra-aortic balloon (iab) was inserted at 0338 and the inner lumen had clotted off almost immediately.Once the patient was back in cvicu, they were unable to transduce pulsatile pressure and unable to aspirate.There was no patient harm or adverse event reported.

Manufacturer Narrative

Initial reporter occupation name: senior buyer.Additional initial reporter: (b)(6), inventory specialist & (b)(6).Additional event site email address: (b)(6).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).

Manufacturer Narrative

Updated fields: b4, g3, h2, h6, h10, h11 corrected fields: d9(return to manufacture date is to be blank) in mfg follow-up #1 in h10 it was mentioned that the product had been returned to the manufacturer, however, the returned product was for another report, therefore no product investigation will be conducted in this report since the device has not been returned to the manufacturer.Reference complaint #(b)(4).

Manufacturer Narrative

Additional reporter(s): (b)(6).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 id # (b)(4).

Event Description

It was reported that the intra-aortic balloon (iab) was inserted on (b)(6) 2023 at 0338 and the inner lumen had clotted off almost immediately.Once the patient was back in cvicu it was discorvered that the pressure waveform was flat, they were unable to transduce pulsatile pressure and unable to aspirate.The iab was romved on (b)(6) 2023 at 1510.There was no patient harm or adverse event reported.Reported via medwatch report # (b)(4): perfusion reported the inner lumen of intra-aortic balloon pump (iabp) catheter was unable to transduce pulsatile pressure and unable to be aspirated immediately following insertion.

• Brand Name: SENSATION PLUS 8FR. 50CC 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: 16942252
• MDR Text Key: 315425123
• Report Number: 2248146-2023-00336
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108605
• UDI-Public: 10607567108605
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0684-00-0576-01
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000288437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 34 KG