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

Model Number	0684-00-0479-07
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during insertion, intra-aortic balloon (iab) unable to withdraw blood for the pressure lumen.Another catheter was used.
Additional Manufacturer Narrative
Due to character limitation, below field are added from e1- event site name - (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
N/a.
Additional Manufacturer Narrative
Updated fields b4 d9 device available for evaluation and date return to manufacture g3 g6 h2 h3 h4 h6 type of investigation investigation findings component code investigation conclusions h11 corrected field h5 on insertion physician was unable to withdraw blood for the pressure lumen another catheter was used the product was returned with the membrane completely unfolded and blood was observed on the iab exterior two kinks were observed on the catheter tubing approximately 77cm and 75.2cm from the iab tip the oneway valve was also returned for evaluation an underwater leak test of the balloon catheter yfitting extracorporeal tubing extender tubing and oneway valve were performed and no leaks were detected a laboratory guidewire was used for the insertion and it advanced smoothly without any resistance the evaluation determined cannot confirm the reported failure of clotted inner lumen a laboratory guidewire was used for the insertion and it advanced smoothly without any resistance 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 nonconforming 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. 34CC IAB (INDIA)
• 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: 23901442
• Report Number: 2248146-2025-0000869
• Device Sequence Number: 10116289
• Product Code: DSP
• UDI-Device Identifier: 10607567109695
• UDI-Public: (01)10607567109695(10)3000401359(17)270709(11)240709
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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: 0684-00-0479-07
• Device Catalogue Number: 0684-00-0479-07
• Device Lot Number: 3000401359
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 12/27/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 55 KG