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	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during therapy, iab catheter was inserted through right femoral artery.The pressure waveform was not sensed in the catheter due to which balloon augmentation failed.Iab did not work inside the patient.There was no patient harm or injury reported.
Additional Manufacturer Narrative
Due to character limit in e1 full event site name: (b)(6).Full initial reporter name: dr.(b)(6).A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Updated fields - b4, d9, g3, g6, h2, h3, h6 (type of investigation, investigation findings, component code, investigation conclusions), h11 corrected field: d4 lot and udi number, d7a, d8 should be empty, d9 additional phone number: (b)(6).The customer reported that during use, the iab catheter was inserted through right femoral artery.The pressure waveform was not sensed in the catheter due to which balloon augmentation failed.Iab did not work inside the patient.No decon or visual inspection performed since product was not returned and could not be evaluated.Therefore, we were unable to confirm or determine a root cause for the reported failure.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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields - b4, g3, g6, h2, h11.Correctional field: d4 expiry date, h4, h5.
Additional Manufacturer Narrative
Updated fields: b4, d9 (device available for eval, return to manufacture date), g3, g6, h2, h3, h6 (type of investigation).Corrected fields: d4 (lot #, exp date, udi #), h4 (manufacture date).The iab was returned with the membrane completely unfolded.No blood was visible on the iab catheter.The technician attempted to insert a laboratory 0.025¿ guide wire through the inner lumen and was able to successfully insert the guide wire.No obstructions were felt.The reported event cannot be confirmed by the evaluation.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.The device meets all product specifications.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.
Event or Problem Description
N/a.

• 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: 23265100
• Report Number: 2248146-2025-0000607
• Device Sequence Number: 15988915
• Product Code: DSP
• UDI-Device Identifier: 10607567109695
• UDI-Public: (01)10607567109695(10)3000372062(17)270402(11)240402
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/22/2026

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: 3000372062
• 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: 09/19/2025
• Supplement Date Received by Manufacturer: 11/27/2025; 11/28/2025; 01/12/2026
• Initial Report FDA Received Date: 10/10/2025
• Supplement Report FDA Received Date: 11/27/2025; 11/28/2025; 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2024
• 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: UNKNOWN.
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 61 KG