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

Catalog Number 0684-00-0604

Device Problem Defective Component (2292)

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

Event Date 03/04/2024

Event Type  malfunction  

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the pressure tubing was closed off at one end.The hospital staff used pressure-resistant tubes that they had on-site, and therapy was continued.There was no patient harm or adverse event reported.

Manufacturer Narrative

Initial reporter: (b)(6).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).

• Brand Name: TRANSRAY PLUS 7.5FR. 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: 18974492
• MDR Text Key: 338567186
• Report Number: 2248146-2024-00166
• 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
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0604
• Device Lot Number: 3000327916
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/11/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ANOTHER COMPANY'S 8FR 10CM SHEATH .CARDIOSAVE.
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 57 KG