MAUDE Adverse Event Report: DATASCOPE CORP. LINEAR 7.5FR. 40CC IAB WITH ACCESSORIES, US ONLY; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0480-01U
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Rupture (1546)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/26/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Due to character limit in block e1 event site name is (b)(6).The device is not available to be 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 the intra-aortic balloon (iab) experienced a catheter rupture.Unfortunately, the patient did not survive.
Event or Problem Description
It was reported that the intra-aortic balloon (iab) catheter experienced a rupture.Unfortunately, the patient did not survive.
Additional Manufacturer Narrative
Updated fields: b4, b5, d8, d9, g3, g6, h2, h3, h6 (medical device ¿ problem code, type of investigation, investigation findings and investigation conclusions), h8, h11 corrected fields: d7a.The iab was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter.The sheath hub was over the membrane.The sheath tubing appears to be broken off from the sheath and not returned.The extender tubing was also returned.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and a leak was detected on the membrane approximately 1.3cm from the rear seal measuring 0.013cm in length.The reported problem 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.Complaint record id #(b)(4).

• Brand Name: LINEAR 7.5FR. 40CC IAB WITH ACCESSORIES, US ONLY
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE CORP.; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: henry pena ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 21558018
• Report Number: 2248146-2025-0000129
• Device Sequence Number: 9261608
• Product Code: DSP
• UDI-Device Identifier: 10607567109527
• UDI-Public: (01)10607567109527(10)30003942370786(17)270604(11)240604
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K041281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0684-00-0480-01U
• Device Catalogue Number: 0684-00-0480-01U
• Device Lot Number: 3000394237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown