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

Catalog Number 0684-00-0605

Device Problem Leak/Splash (1354)

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

Event Date 03/17/2024

Event Type  malfunction  

Event Description

It was reported that immediately after initiation of intra-aortic balloon (iab) therapy, there was an "iab catheter inspection required (flow control)" alarm.Blood was also seen in the extender tubing.The iab was replaced and therapy was provided.There was no patient harm or adverse event reported.

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.Reference complaint # (b)(4).

Manufacturer Narrative

The product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter.The extender tubing was also returned.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and a leak was observed at the iab tip.The root cause of the reported failure iab - alarm, check iab catheter & leak, blood in tubing¿ was identified as damage at the device¿s tip.This damage occurred after shipment of the device.The dhr was reviewed and the iab was deemed acceptable and met quality standard prior to leaving the facility.Furthermore, each iab undergoes two leak tests before being released.The root cause of damage to the device¿s tip cannot be determined as it occurred after shipment of the device and was out of getinge¿s control.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 #1004976.

Event Description

N/a.

• Brand Name: TRANSRAY PLUS 7.5FR. 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: 19061194
• MDR Text Key: 339690945
• Report Number: 2248146-2024-00204
• 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
• Report Date: 05/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 3000320635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 05/28/2024
• Supplement Dates FDA Received: 05/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1