MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD TRANS-RAY PLUS 7.5 FR. 35CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0604

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

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

Event Date 07/17/2022

Event Type  malfunction  

Event Description

It was reported that after approximately two days of intra-aortic balloon (iab) therapy the console generated a catheter restriction alarm.Blood was also seen inside the catheter.The iab was removed immediately.Since a thrombus had formed in the iab, it could not be removed from the sheath insertion part.Therefore, the catheter shaft was cut and removed in the ope chamber.A new iab was inserted, however, immediately after insertion it ruptured.Blood was seen in the tubing and had reached inside the console.A third iab and a different console were then used to successfully continue therapy.There was no patient harm or adverse even reported.This report is for the second iab used in this event.A separate report has been submitted for the first iab under mfg report number 2248146-2022-00611.

Manufacturer Narrative

Event site postal code: (b)(6).Complete event site city: (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).Device not returned.

Event Description

N/a.

Manufacturer Narrative

The iab was returned cut in two parts with the membrane completely unfolded and blood on the interior and exterior of the catheter.The sheath, extender, and pressure tubing were also returned.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal, pressure, and extender tubing was performed and one leak was detected on the rear seal of the membrane.The reported problem was most likely triggered by the leak found on the rear seal of membrane.The evaluation confirms the reported problem.A non-conforming material report 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.

Manufacturer Narrative

The iab was returned cut in two parts with the membrane completely unfolded and blood on the interior and exterior of the catheter.The sheath, extender, and pressure tubing were also returned.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal, pressure, and extender tubing was performed and one leak was detected on the rear seal of the membrane.The reported problem was most likely triggered by the leak found on the rear seal of membrane.The evaluation confirms the reported problem.Engineering has concluded that the device left the facility within specification.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: TRANS-RAY PLUS 7.5 FR. 35CC 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: 15210818
• MDR Text Key: 305160962
• Report Number: 2248146-2022-00617
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2024
• Device Catalogue Number: 0684-00-0604
• Device Lot Number: 3000146033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARDIOSAVE.
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 61 KG