MAUDE Adverse Event Report: DATASCOPE CORP. MEGA 8FR. 50CC IAB (WITH STATLOCK); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0296-01
Medical Device Problem Codes	Leak/Splash (1354); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, intra-aortic balloon (iab) had alerted occlusion at 0725hrs and blood in line flushing.There was no patient harm.
Additional Manufacturer Narrative
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).
Additional Manufacturer Narrative
3000240707-2025-00125, 3000240707-2025-00126, 3000240707-2025-00127, 3000240707-2025-00128, 3000240707-2025-00129, 3000240707-2025-00130, 3000240707-2025-00131, 3000240707-2025-00132, 3000240707-2025-00133, 3000240707-2025-00134, 3000240707-2025-00135, 3000240707-2025-00136, 3000240707-2025-00137, 3000240707-2025-00138, 3000240707-2025-00139, 3000240707-2025-00140, 3000240707-2025-00141, 3000240707-2025-00142, 3000240707-2025-00143, 3000240707-2025-00144, 3000240707-2025-00145, 3000240707-2025-00146, 3000240707-2025-00147, 3000240707-2025-00148, 3000240707-2025-00149, 3000240707-2025-00150, 3000240707-2025-00151, 3000240707-2025-00152, 3000240707-2025-00153, 3000240707-2025-00154, 3000240707-2025-00155, 3000240707-2025-00157, 3000240707-2025-00158, 3000240707-2025-00159, 3000240707-2025-00160, 3000240707-2025-00161, 3000240707-2025-00162, 3000240707-2025-00163, 3000240707-2025-00164, 3000240707-2025-00165, 3000240707-2025-00166, 3000240707-2025-00167, 3000240707-2025-00168, 3000240707-2025-00169, 3000240707-2025-00170, 3000240707-2025-00171, 3000240707-2025-00172, 3000240707-2025-00173, 3000240707-2025-00174, 3000240707-2025-00175, 3000240707-2025-00176, 3000240707-2025-00177, 3000240707-2025-00178, 3000240707-2025-00179, 3000240707-2025-00180, 3000240707-2025-00181, 3000240707-2025-00182, 3000240707-2025-00183, 3000240707-2025-00184, 3000240707-2025-00185, 3000240707-2025-00186, 3000240707-2025-00187, 3000240707-2025-00188, 3000240707-2025-00189, 3000240707-2025-00190, 3000240707-2025-00191, 3000240707-2025-00192, 3000240707-2025-00193, 3000240707-2025-00194, 3000240707-2025-00195, 3000240707-2025-00196, 3000240707-2025-00197, 3000240707-2025-00198, 3000240707-2025-00199, 3000240707-2025-00200, 3000240707-2025-00201, 3000240707-2025-00202.
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.Based on the event description iabp inserted on (b)(6) 2025 at 07hrs.On (b)(6) 2025, nursing staff noticed blood in line.All connections secure.Line flushing iabp alerted occlusion at 0725hrs.Blood in line.Again, the iabp removed.The product was returned with the membrane completely unfolded and blood on the interior and exterior of the iab.Between catheter and sheath, the iab was returned.Cut at the extracorporeal tubing and a piece not returned.The non-maquet sheath was returned.Covering the catheter tubing, the pressure tubing was also returned.Cut for evaluation.No damage was found on the returned iab.An underwater leak test of the catheter tubing, inner lumen extracorporeal tubing, extender tubing and pressure tubing and one leak was observed on the membrane 267cm away from the tip and measures 0015 in.0038 cm.Long.The reported problems were 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 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 the past three 3 months.Based on the rational provided above, no escalation to the capa process is required.

• Brand Name: MEGA 8FR. 50CC IAB (WITH STATLOCK)
• 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: 23901488
• Report Number: 2248146-2025-0000876
• Device Sequence Number: 10144373
• Product Code: DSP
• UDI-Device Identifier: 10607567108001
• UDI-Public: (01)10607567108001(10)3000456801(17)280227(11)250227
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K133074
• 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,Followup
• Report Date (Section B): 02/27/2026

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: 0684-00-0296-01
• Device Catalogue Number: 0684-00-0296-01
• Device Lot Number: 3000456801
• 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: 12/05/2025
• Supplement Date Received by Manufacturer: 02/18/2026; 02/27/2026
• Initial Report FDA Received Date: 12/27/2025
• Supplement Report FDA Received Date: 02/19/2026; 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 90 KG