MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD MEGA 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0296-01

Device Problems Difficult to Insert (1316); Unraveled Material (1664); Material Deformation (2976)

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

Event Date 06/09/2022

Event Type  malfunction  

Manufacturer Narrative

Occupation: operations coordinator.Event site full name: (b)(6) hospital.The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.Complaint record id # (b)(4).

Event Description

It was reported that while prepping for insertion, the customer noticed a tear in the intra-aortic balloon (iab).A second iab was then opened, but the membrane was unfurled and it could not be inserted through the sheath.Neither of the iabs had been inserted into the patient.A third iab was inserted successfully.There was no patient harm or adverse event reported.This report is for the second iab in this event.A separate report has been submitted for the first iab under mfg report number 2248146-2022-00509.

Manufacturer Narrative

Complaint record id # (b)(4).

Manufacturer Narrative

The iab was returned with the membrane completely unfolded and the one-way valve attached.No blood was visible on the catheter.No tear or damage was observed on the returned iab.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.The reported event cannot be confirmed by the evaluation.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 #(b)(4).

• Brand Name: MEGA 8FR. 50CC 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: 14859970
• MDR Text Key: 302934280
• Report Number: 2248146-2022-00511
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108001
• UDI-Public: 10607567108001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0684-00-0296-01
• Device Catalogue Number: 0684-00-0497
• Device Lot Number: 3000209759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 127 KG