MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION 7FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0469-01
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Rupture (1546)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that sensation 7fr.34cc intra-aortic balloon pump (iabp) had a balloon rupture resulting the blood entering through the balloon to the tubing.
Additional Manufacturer Narrative
Device has not been returned to manufacturer, supplemental report will be submitted upon completion of additional findings.
Additional Manufacturer Narrative
Updated fields: b4, d8, d9, g1(contact person mfg site), g3, g6, h2, h3, h6 (type of investigation, investigation findings and investigation conclusions), h11 corrected field: e1 (event site address).The product was returned with the membrane completely unfolded and blood on the exterior and interior of the catheter, as well as inside the inner lumen.The extender tubing was also returned.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal tubing and extender tubing was performed and a leak was detected on the membrane approximately 2cm from the rear seal measuring 0.005in/0.0013cm length.The reported problems were most likely triggered by a leak which was found on the membrane.The leak size suggests that a sharp object may have caused it, no marks were found around the leak.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
N.A.
Additional Manufacturer Narrative
Updated fields: b4, b5, d9,e1(initial reporter, event site address, event site telephone,event site email), e3, g3, g6, h2, h3, h6 (health effect ¿ clinical code, type of investigation, investigation findings, component codes, investigation conclusions, health effect ¿ impact codes), h11.Corrected fields: d4 (lot no., udi no.), d10.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.Complaint id: (b)(4).
Event or Problem Description
It was reported that during iab therapy, the intra-aortic balloon pump (iabp) had a balloon rupture resulting the blood entering through the balloon to the tubing.No patient harm or injury was reported.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h6 (medical device problem code), h11 corrected field: h6 (investigation findings).
Event or Problem Description
N/a.

• Brand Name: SENSATION 7FR. 34CC 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: 21534354
• Report Number: 2248146-2025-0000113
• Device Sequence Number: 7054863
• Product Code: DSP
• UDI-Device Identifier: 10607567106755
• UDI-Public: (01)10607567106755(10)3000310577(17)260504(11)230504
• Combination Product (Y/N): N
• Initial Reporter Country: MC
• PMA/510(K) Number: K063525
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/15/2025

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 Expiration Date: 05/04/2026
• Device Model Number: 0684-00-0469-01
• Device Catalogue Number: 0684-00-0469-01
• Device Lot Number: 3000310577
• 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: 03/04/2025
• Supplement Date Received by Manufacturer: 05/07/2025; 07/28/2025; 09/15/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 05/07/2025; 07/31/2025; 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2023
• 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: CARDIOSAVE HYBRID
• Patient Sex: Unknown