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

Model Number 0684-00-0498-01

Device Problems Backflow (1064); Disconnection (1171); Leak/Splash (1354)

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

Event Date 02/15/2023

Event Type  malfunction  

Event Description

It was reported that after five days of intra-aortic balloon (iab) therapy, the console generated a leak in iab circuit alarm and an iab disconnected alarm.After six days of therapy, a blood detected alarm was generated and blood was found in the tubing.The iab was removed and it was discovered that the lumen was broken.A new iab was inserted to continue therapy.There was no patient harm or adverse event reported.

Manufacturer Narrative

(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).

Manufacturer Narrative

The iab was returned with the membrane completely unfolded.The extender tubing was also returned.No blood was visible on the catheter.A visual examination of the product detected the inner lumen within the membrane was completely separated within a kink approximately 26.9cm from iab tip.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and no other leaks were detected.The break found in the inner lumen appears to have been the result of a severe kink, which eventually failed causing the reported problems.It is difficult to determine when the break occurred but it is possibly a result of patient movement during the procedure.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).

Event Description

N/a.

• 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: 16494445
• MDR Text Key: 310877683
• Report Number: 2248146-2023-00158
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107301
• UDI-Public: 10607567107301
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K091449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0684-00-0498-01
• Device Catalogue Number: 0684-00-0497
• Device Lot Number: 3000170980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 67 KG