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

Model Number	0684-00-0479-01
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event site postal code: (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 or Problem Description
It was reported that after approximately 2.5 days of intra-aortic balloon (iab) therapy, blood was seen in the extracorporeal tubing and the console generated an iab catheter restriction alarm.Patient was managed with inotropes.There was no patient harm or adverse event reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Device evaluation: the iab 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 returned sheath was not a maquet product.The extender tubing and one-way valve were also returned.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and externder tubing was performed and a leak was detected on the membrane approximately 1.3cm 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.; 15 law drive; fairfield NJ
• Manufacturer (Section G): DATASCOPE CORP.; 15 law drive; fairfield NJ
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ
• MDR Report Key: 19973400
• Report Number: 2248146-2024-00499
• Device Sequence Number: 7048038
• Product Code: DSP
• UDI-Device Identifier: 10607567106557
• UDI-Public: (01)10607567106557(10)3000349897(17)261117(11)231117
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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 Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2024

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 Model Number: 0684-00-0479-01
• Device Catalogue Number: 0684-00-0479-01
• Device Lot Number: 3000349897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Supplement Date Received by Manufacturer: 09/08/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARDIOSAVE
• Patient Sex: Unknown