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

Model Number 0684-00-0568-01

Device Problem Difficult to Advance (2920)

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

Event Date 04/14/2021

Event Type  malfunction  

Manufacturer Narrative

Occupation: nurse manager event site postal code: (b)(6). Event site state - (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).

Event Description

It was reported that during insertion of the intra-aortic balloon (iab) there was resistance encountered when the iab was inserted halfway into the sheath. The iab was removed from the sheath and it was discovered that the iab was broken. A new iab was inserted. There was no patient harm or adverse event reported.

• Brand Name: SENSATION 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: dorota wolpiuk ; 15 law drive; fairfield, NJ
• MDR Report Key: 11776220
• MDR Text Key: 249024509
• Report Number: 2248146-2021-00286
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K122628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 0684-00-0568-01
• Device Catalogue Number: 0684-00-0567
• Device Lot Number: 3000126872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2020
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial