MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number	0684-00-0474
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter occupation: mn, service line nurse manager.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 or Problem Description
It was reported that a leak occurred after less than 24 hours of intra-aortic balloon (iab) therapy.It was noted that the console had generated a gas loss in iab circuit alarm.A new iab was inserted to continue therapy.There was no patient harm or adverse event reported.
Additional 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 extender tubing was also returned.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and one leak was detected on the membrane approximately 1.5cm from the rear seal measuring 0.025cm 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: LINEAR 7.5 FR. 34CC IAB
• Common Device Name: 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: 17469541
• Report Number: 2248146-2023-00490
• Device Sequence Number: 7090550
• Product Code: DSP
• UDI-Device Identifier: 10607567109503
• UDI-Public: 10607567109503
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K041281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/20/2025
• Device Catalogue Number: 0684-00-0474
• Device Lot Number: 3000250770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2023
• Supplement Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 63 KG