MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0470-01

Device Problems Inflation Problem (1310); Inappropriate Waveform (2536); Pressure Problem (3012)

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

Event Date 06/13/2023

Event Type  malfunction  

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the customer could not calibrate the optical sensor or obtain an arterial pressure line.The patient was supported with electrocardiogram (ecg) only.It was noted that the console generated a catheter restriction alarm and the iab could not be inflated.A new iab was inserted to continue therapy.There was no patient harm or adverse event reported.

Manufacturer Narrative

Initial reporter occupation: perfusionist.Event site postal code: (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

The product was returned with the membrane completely unfolded and traces of blood on the exterior of the catheter.The extender tubing was also returned.Two kinks were found on the catheter tubing near the y-fitting approximately 71.1cm and 76.2cm from iab tip.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, extracorporeal and extender tubing was performed and no leaks were detected.A sensor output test was performed and the sensor was found to be within specification.The iab was placed on the cadiosave pump and pumped for two hours which represents one complete autofill cycle.The iab pumped normally and no alarm sounded from the pump.The reported events cannot be confirmed by the evaluation.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).

• Brand Name: SENSATION 7FR. 40CC 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: 17277312
• MDR Text Key: 318769439
• Report Number: 2248146-2023-00431
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2024
• Device Model Number: 0684-00-0470-01
• Device Catalogue Number: 0684-00-0434
• Device Lot Number: 3000156375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 75 KG