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

Catalog Number 0684-00-0575

Device Problems Restricted Flow rate (1248); Optical Problem (3001); Migration (4003)

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

Event Date 10/06/2023

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation: bsn, rn, ccrn, clinical resource coordinator 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).H3 other text : device not returned.

Event Description

It was reported that the patient was post-coronary artery bypass graft (cabg) and required intra-aortic balloon (iab) therapy.Six hours post-op, the patient became significantly restless and anxious.The nurse had difficulty keeping iab insertion leg immobilized.Several hours later, the console generated a fiber optic sensor failure alarm.They switched to the inner lumen to transduce but it was believed that the line was clotted.It was then discovered that the iab placement was very shallow so the iab was removed.There were no issues after removal and the patient was transferred out of the icu the next day.There was no patient harm or adverse event reported.

Event Description

N/a.

Manufacturer Narrative

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

Manufacturer Narrative

After further investigation, it was identified that this complaint event has been reported already under mfg report number 2248146-2023-00636.Please refer to mfg report number 2248146-2023-00636 for all information for this complaint event.Please cancel this mfg report number in your database.

Event Description

After further investigation, it was identified that this complaint event has been reported already under mfg report number 2248146-2023-00636.Please refer to mfg report number 2248146-2023-00636 for all information for this complaint event.Please cancel this mfg report number in your database.

• 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: 18030519
• MDR Text Key: 327755725
• Report Number: 2248146-2023-00640
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000321167
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/26/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 95 KG