MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD TRANS-RAY PLUS 7.5 FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0605

Device Problems Break (1069); Pressure Problem (3012)

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

Event Date 10/22/2023

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 when initiating intra-aortic balloon (iab) therapy the arterial pressure did not appear on the cardiosave intra-aortic balloon pump (iabp).An attempt was made to remove the sensor connector and re-insert it into the iabp port.It was noted that the connector cover had been broken/opened and there appeared to be no trace of the adhesive agent at the fitting part of the connector cover.Therapy was continued by obtaining the arterial pressure via transducer.There was no patient harm or adverse event reported.

Manufacturer Narrative

Remove medical device ¿ problem code 3012.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.Reference complaint #(b)(4).

Event Description

N/a.

Manufacturer Narrative

The sensor connector was returned in two halves along with the sensor cable and no blood was visible on the components.The iab catheter was not returned.Both connectors halves were sent for ftir (fourier transform infrared spectroscopy) analysis material testing of adhesive along the seam of the connector halves and testing confirmed that adhesive was present on the connectors seam.See attached ftir report.The evaluation confirmed the reported broken sensor connector.We are unable to determine how this may have occurred.Per sop (b)(4) rev bg for the application of adhesive to the connector halves were followed.Reference complaint #(b)(4).

• Brand Name: TRANS-RAY PLUS 7.5 FR. 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: 18226291
• MDR Text Key: 329202040
• Report Number: 2248146-2023-00690
• Device Sequence Number: 1
• Product Code: DSP
• 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,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARDIOSAVE
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 65 KG