MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION 7FR INTRA-AORTIC BALLOON PUMP

Catalog Number 0684-00-0469-01U

Device Problem Difficult to Insert (1316)

Patient Problem No Code Available (3191)

Event Date 05/28/2016

Event Type  malfunction  

Event Description

Iabp balloon failed to hold negative pressure, could not be inserted through sheath.

• Brand Name: SENSATION 7FR
• Type of Device: INTRA-AORTIC BALLOON PUMP
• Manufacturer (Section D): DATASCOPE CORP.; fairfield NJ 07004
• MDR Report Key: 5764636
• MDR Text Key: 48734549
• Report Number: MW5063188
• Device Sequence Number: 1
• Product Code: DSP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/28/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/13/2018
• Device Catalogue Number: 0684-00-0469-01U
• Device Lot Number: 3000016155
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage