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

Catalog Number 0684-00-0604

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2019

Event Type  malfunction  

Manufacturer Narrative

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

It was reported that during insertion of the intra-aortic balloon (iab), the balloon did not advance through the sheath into the descending aorta.The sheath deviated from the deployed position.The iab catheter was reported to be difficult to remove from the sheath, so it was percutaneously removed as a unit with the sheath (as described in the instructions for use) without any issues.The balloon was replaced.There was no reported injury to the patient.

• Brand Name: TRANS-RAY PLUS 7.5 FR. 35CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 8734391
• MDR Text Key: 149197710
• Report Number: 2248146-2019-00565
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2022
• Device Catalogue Number: 0684-00-0604
• Device Lot Number: 3000087647
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/10/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1