MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION PLUS 8FR. 50CC IAB & ACCESSORIES (W/PRESSURE TUBES, NO STYLET); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0576-01
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other contact phone number: (b)(6).Due to characterization limit e1: event site name: (b)(6).Clotted inner lumen is a blockage of the catheter¿s inner channel, typically caused by blood clot thrombus formation within that lumen.When the inner lumen becomes occluded by a blood clot, it can no longer transmit accurate arterial pressure.Inner lumen importance the inner lumen of an iab catheter is used to monitor arterial pressure waveforms.Causes of clotted inner lumen are as follows 1.Inadequate flushing of the inner lumen.2.Kink in the inner lumen.3.Iab remaining inactive or in standby for more than 30 minutes.
Event or Problem Description
(b)(6) rn calls from the icu stating they just received a patient transferred from an outlying hospital to (b)(6).He starts to (b)(6) rn called into the emergency support program line to request support from the icu, stating they had just received a patient transferred from an outlying hospital to (b)(6).He began to describe that they had transferred the therapy to their arrow iabp at (b)(6) when (b)(6) rn from transport joined the call.(b)(6) stated he wanted to verify what teleflex had already communicated regarding a clotted inner lumen of the sensation plus 8fr 50cc iab.He wanted to confirm that the catheter did not need to be removed due to the clotted inner lumen.Esp personnel verified that information as accurate and reviewed management of the clotted inner lumen with him.No harm or injury to the patient was reported.

• Brand Name: SENSATION PLUS 8FR. 50CC IAB & ACCESSORIES (W/PRESSURE TUBES, NO STYLET)
• 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: 25044263
• Report Number: 2248146-2026-0000974
• Device Sequence Number: 9725720
• Product Code: DSP
• UDI-Device Identifier: 10607567108605
• UDI-Public: (01)10607567108605
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K133074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/30/2026

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: 0684-00-0576-01
• Device Catalogue Number: 0684-00-0576-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown