MAUDE Adverse Event Report: DATASCOPE CORP. LINEAR 7.5FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0479-01
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.Complaint record id: (b)(4).
Event or Problem Description
It was reported that during use on patient, the linear 34cc iab (intra-aortic balloon) had catheter rupture, there was no patient injury or harm reported.
Additional Manufacturer Narrative
Updated fields: b4, d9, g3, g6, h2, h3, h6, (type of investigation, investigation findings, investigation conclusions), h11 corrected fields: d4 (lot no., udi no.), d7a the product was returned with the membrane completely unfolded with blood on the interior and exterior of the catheter.The extender tubing was also returned.A visual examination of the product detected the inner lumen within the membrane was completely separated within a kink approximately 24.1cm from iab tip.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and no other leaks were detected.The evaluation determined an inner lumen break within an inner lumen kink causing the reported problem.It is difficult to determine when or how this occurred.The evaluation confirmed the reported problem.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.Complaint id no.: (b)(4).
Event or Problem Description
N/a.

• Brand Name: LINEAR 7.5FR. 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: henry pena ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 21249720
• Report Number: 2248146-2025-0000045
• Device Sequence Number: 18156693
• Product Code: DSP
• UDI-Device Identifier: 10607567106557
• UDI-Public: (01)10607567106557(10)3000332804(17)260831(11)230831
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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: 08/31/2026
• Device Model Number: 0684-00-0479-01
• Device Catalogue Number: 0684-00-0479-01
• Device Lot Number: 3000332804
• 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: 01/09/2025
• Supplement Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2023
• 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: UNKNOWN.
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 81 KG