MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION 7FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0470-01
Medical Device Problem Codes	Restricted Flow rate (1248); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during an intra-aortic balloon therapy a catheter restriction alarm was reported during use of the iab catheter.Upon assessment, a noticeable kink was observed at the insertion site, likely due to a high sheath placement and tight dressing.The catheter was repositioned by the physician; however, the restriction alarm continued to occur approximately every 10 minutes.
Additional Manufacturer Narrative
Due to character limit in block e1 event site name: (b)(6) regional medical center.A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated field- b4, g3, g6, h2, h11 corrected field- h6-investigation findings, investigation conclusions.
Additional Manufacturer Narrative
Updated fields: b4, d8, d9, g3, g6, h2, h3, h6 (type of investigation, investigation findings, medical device problem code, component codes and investigation conclusions), h11 corrected field: b5.The product was returned with the membrane completely unfolded and blood on the exterior of the catheter.One kink was observed on the catheter tubing approximately 76.2cm from the iab tip.The pressure tubing and three way stopcock were also returned for evaluation.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal tubing and pressure tubing was performed, and no leaks were detected.The iab was placed on the cardiosave pump and pumped for two hours which represents one complete autofill cycle.The iab pumped normally, and no alarm sounded from the pump.The reported events cannot be confirmed by the evaluation.The alarm could have resulted from the kink found on the catheter tubing.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.
Event or Problem Description
It was reported during an intra-aortic balloon therapy a catheter restriction alarm was reported during use of the iab catheter.Upon assessment, a noticeable kink was observed at the insertion site, likely due to a high sheath placement and tight dressing.The catheter was repositioned by the physician; however, the restriction alarm continued to occur approximately every 10 minutes.No patient harm or injury reported.

• Brand Name: SENSATION 7FR. 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: 22553014
• Report Number: 2248146-2025-0000399
• Device Sequence Number: 9559888
• Product Code: DSP
• UDI-Device Identifier: 10607567106779
• UDI-Public: (01)10607567106779(10)3000433588(17)271202(11)241202
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122628
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/05/2025

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: 0684-00-0470-01
• Device Catalogue Number: 0684-00-0470-01
• Device Lot Number: 3000433588
• 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: 07/06/2025
• Supplement Date Received by Manufacturer: 08/25/2025; 09/05/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 09/03/2025; 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2024
• 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: INTRA-AORTIC BALLOON PUMP (IABP).
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 80 KG