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

Catalog Number 0684-00-0293

Device Problems Inability to Auto-Fill (1044); Leak/Splash (1354)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/17/2024

Event Type  Injury  

Manufacturer Narrative

Event site address: (b)(6).Event site postal code: (b)(6).Event site telephone - (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.Reference complaint #(b)(4).H3 other text : device not returned.

Event Description

It was reported that after 6 hours of intra-aortic balloon (iab) therapy, on (b)(6) 2024, an auto-fill failure alarm occurred and the iab would not inflate.Upon removal of the iab, it was observed that the iab ruptured.The patient experienced unstable circulation and required a secondary puncture for drainage.The iab was replaced to continue therapy.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter and between the catheter and the sheath.The sheath tubing was observed to be kinked 3cm from its tip.Underneath the sheath the catheter tubing was found kinked approximately 34.8cm from iab tip.Additionally a second kinked was observed on the catheter tubing near the y-fitting approximately 76.2cm from iab tip.Photos were provided and reviewed.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and a leak was detected on the membrane approximately 1cm from the rear seal measuring 0.013cm in length.The reported problems was most likely triggered by a leak which was found on the membrane.Under magnification, a whitish patch was observed around the leak.This whitish patch is the typical appearance of an abrasion mark which is caused by calcified plaque in the aorta.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 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: brian schaeffer ; 15 law drive; fairfield, NJ
• MDR Report Key: 18839115
• MDR Text Key: 336918913
• Report Number: 2248146-2024-00136
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567109039
• UDI-Public: 10607567109039
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K120868
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0293
• Device Lot Number: 3000275977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female