MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD TRANS-RAY PLUS 7.5 FR. 40CC IAB; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 0684-00-0605

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

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

Event Date 11/07/2022

Event Type  malfunction  

Manufacturer Narrative

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).

Event Description

It was reported that after inserting the intra-aortic balloon (iab) and initiating therapy, the arterial pressure was not displayed on the cardiosave intra-aortic balloon pump (iabp).The customer tried connecting to another cardiosave iabp, but the blood pressure was not displayed either.There was no patient harm or adverse event reported.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and blood on the exterior of the catheter.A kink was found on the catheter tubing near the y-fitting approximately 76.2cm from the iab tip.A second kink was found on the catheter tubing and on the inner lumen approximately 70.4cm iab tip.The extender and pressure tubing were also returned.A sensor output test was performed and a pressure reading could not be obtained.The technician then used an optical light to detect any breaks in the sensor's optical fiber and found a break within the y-fitting.The optical fiber was found to be broken, confirming the reported problems.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 Description

N/a.

• Brand Name: TRANS-RAY PLUS 7.5 FR. 40CC IAB
• Type of Device: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• 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: 15870776
• MDR Text Key: 307704760
• Report Number: 2248146-2022-00927
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Type of Report: Initial,Followup
• Report Date: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0605
• Device Lot Number: 3000162142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARDIOSAVE
• Patient Sex: Male
• Patient Weight: 71 KG