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

Model Number	0684-00-0480-01
Medical Device Problem Codes	Restricted Flow rate (1248); Leak/Splash (1354); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limitation, below field are added from e.1.: event site name: (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that balloon catheter intra-aortic balloon (iab) was inserted successfully.Later that evening, nursing staff observed blood reflux in the catheter, raising suspicion of a possible iab rupture.There was no harm reported.
Additional Manufacturer Narrative
Updated fields: a2, a3a, a4, b4, g3, g6, h2, h11.
Additional Manufacturer Narrative
Updated fields: b4, g3, g4 (pma/510k), g6, h2, h11.Corrected field: h6 (investigation conclusions).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields - b4, d4 udi number, expiry date, d9 device available for eval and date return to manufacture, g3, g6, h2, h3, h4, h6 (type of investigation, investigation findings, component code, investigation conclusions), h11.Corrected field: d4 lot number, d7a, d10, e4, h6 medical device problem code, e1- due to character limit in e1 initial reporter name is (b)(6).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 over the catheter but it was not a maquet product.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and a leak was detected on the membrane approximately 2.3cm 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.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses the reported failure.There were no ncmrs identified which could cause or contribute to the reported failure.The investigation does not indicate that the device was inadvertently released as non-conforming or an adulterated product or was a counterfeit.The complaint history review did not identify an adverse trend (increase in number of complaints over past three (3) months).Based on the rational provided above, no escalation to the capa process is required.

• Brand Name: LINEAR 7.5FR. 40CC IAB
• 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.; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: ewelina chorlowska ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 23602818
• Report Number: 2248146-2025-0000746
• Device Sequence Number: 13073864
• Product Code: DSP
• UDI-Device Identifier: 10607567106564
• UDI-Public: (01)10607567106564(10)3000461006(17)280317(11)250317
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K041281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/08/2026

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: 0684-00-0480-01
• Device Catalogue Number: 0684-00-0480-01
• Device Lot Number: 3000461006
• 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: 10/29/2025
• Supplement Date Received by Manufacturer: 01/02/2026; 01/08/2026; 01/08/2026
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 01/06/2026; 01/08/2026; 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2025
• 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 Age: 63 YR
• Patient Sex: Male
• Patient Weight: 72 KG