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

Catalog Number 0684-00-0433

Device Problems Difficult to Advance (2920); Migration (4003)

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

Event Date 11/22/2023

Event Type  malfunction  

Event Description

It was reported that after insertion, the intra-aortic balloon (iab) was seen via imaging migrating down about an inch.When this was noticed the doctor attempted to advance the iab but was unsuccessful.The iab was removed and replaced with a second iab.However, the same issue occurred so the second iab was removed as well.The doctor did not continue with therapy.There was no patient harm or adverse event reported.This report is for the 2nd iab involved.A separate report has been submitted for the 1st iab under mfg report number 2248146-2023-00709.

Manufacturer Narrative

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).

Manufacturer Narrative

The product was returned with the membrane completely unfolded and traces of blood on the exterior of the catheter.The sheath was not returned for evaluation.The sensor cable was found to have a cut on it approximately 2.8cm from the y-fitting.The inner lumen was found occluded with dried blood.The occlusion was unable to be cleared.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks or holes were detected.A leak may impact the ability to maintain vacuum.The iab was placed on the cardiosave pump and the iab fully inflated.No alarm sounded from the pump.We are unable to confirm the reported iab migration and difficulty during insertion because of the returned condition of the catheter and we are unable to mimic the clinical setting.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 Description

N/a.

• 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: 18318518
• MDR Text Key: 330466715
• Report Number: 2248146-2023-00713
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567106755
• UDI-Public: 10607567106755
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2024
• Device Catalogue Number: 0684-00-0433
• Device Lot Number: 3000142798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2023
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 95 KG