MAUDE Adverse Event Report: DATASCOPE CORP. LINEAR 7.5FR. 40CC IAB (INDIA); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0480-07
Medical Device Problem Codes	Inability to Auto-Fill (1044); Fluid/Blood Leak (1250); Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that during use, the linear 7.5fr.40cc intra-aortic balloon (iab) was raptured and balloon did not inflate.There was blood in the tubing and console had an autofill failure alarm.There was no patient harm or injury.
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
Other contact phone number: (b)(6).Other contact email:(b)(6) updated field: b4, d9, g3, g6, h2, h3, h6(type of investigation, investigation findings, investigation conclusions), h11.Corrected field: d9.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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, d9, g3, g6, h2, h3, h6(type of investigation, investigation findings, conclusion), h11.The iab was returned with the membrane completely unfolded with the one way valve attached.The inner lumen was found occluded with dried blood.The occlusion was unable to be cleared.An underwater leak test of the balloon catheter y fitting and extra corporeal tubing was performed and a leak was observed on the catheter tubing approximately 76.2cm from iab tip.The condition of the iab as received indicated a penetration on the catheter tubing.The penetration found in the catheter tubing appears to have been caused by a sharp object.We are unable to determine how this may have occurred.The evaluation confirmed the reported problems.A lot history record review was completed for the reported product.No non conformances 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 months.Based on the rational provided above no escalation to the capa process is required.
Additional Manufacturer Narrative
Updated fields - b4, g3, g6, h2, h6 (investigation findings).

• Brand Name: LINEAR 7.5FR. 40CC IAB (INDIA)
• 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: 24065860
• Report Number: 2248146-2026-0000283
• Device Sequence Number: 13332686
• Product Code: DSP
• UDI-Device Identifier: 10607567109718
• UDI-Public: (01)10607567109718(10)3000432540(17)271119(11)241119
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K041281
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/07/2026

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: 0684-00-0480-07
• Device Catalogue Number: 0684-00-0480-07
• Device Lot Number: 3000432540
• 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: 12/24/2025
• Supplement Date Received by Manufacturer: 02/11/2026; 04/10/2026; 05/07/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 02/13/2026; 04/16/2026; 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2024
• 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: UNKNOWN.
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 77 KG