MAUDE Adverse Event Report: DATASCOPE CORP. MEGA 7.5FR. 30CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0294-01
Medical Device Problem Codes	Device Contaminated During Manufacture or Shipping (2969); Moisture or Humidity Problem (2986)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character restrictions in block e1, e1 event site full name is (b)(6).E1 contact person full name is (b)(6).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).
Event or Problem Description
It was reported that upon opening the mega 30 intra-aortic balloon (iab) box, a condensation-like material was observed inside the balloon¿s sterile packaging.There were no patients involved.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2.Corrected fields: d1, d4 (version or model no., catalog no., udi no.).Complaint id no.: (b)(4).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Corrected fields: h6 (medical device ¿ problem code).A mega 7.5fr 30cc catheter kit was returned intact and sealed.Clear fluid was found inside the product packaging.The evaluation consisted of a functional, visual and chemical analysis inspection confirming the presence of fluid inside the packaging.A sample of the fluid has been tested via infrared spectrum analysis and found to be silicone.This fluid is used as a lubricant during the manufacturing process.It has been determined to be biocompatible, does not affect the function of the device, and poses no risk to the patient.A device and 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.The device meets all product specifications.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).

• Brand Name: MEGA 7.5FR. 30CC 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: 21534943
• Report Number: 2248146-2025-0000116
• Device Sequence Number: 12696650
• Product Code: DSP
• UDI-Device Identifier: 10607567107950
• UDI-Public: (01)10607567107950(10)3000313709(17)260613(11)230613
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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): 04/29/2025

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: 06/13/2026
• Device Model Number: 0684-00-0294-01
• Device Catalogue Number: 0684-00-0294-01
• Device Lot Number: 3000313709
• 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: 02/18/2025
• Supplement Date Received by Manufacturer: 03/19/2025; 04/29/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 03/25/2025; 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown