MAUDE Adverse Event Report: DATASCOPE CORP. MEGA 8FR. 50CC IAB (WITH STATLOCK & APA); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0296-02
Medical Device Problem Codes	Break (1069); Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during intra aortic balloon therapy, the catheter was damaged and unable to cross properly.There was no harm or injury reported to the patient.
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.(b)(4).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4; d9; g3; g6; h2; h3; h6 problem code, type of investigation, investigation findings, investigation conclusion, component code, h11.Corrected fields: d1; d4 model number, catalog number udi number the product was returned with the membrane completely unfolded.Blood was observed on the exterior of the iab, between the iab and sheath and inside of the inner lumen.After cleaning the iab from the blood, no blood was observed inside.The sheath was returned covering the catheter tubing.The extender tubing, pressure tubing and three-way stopcock were also returned for evaluation.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal tubing, extender tubing and pressure tubing was performed, and no leaks were detected.We are unable to confirm the reported failure by the evaluation.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.We are unable to confirm the reported failure by the evaluation.

• Brand Name: MEGA 8FR. 50CC IAB (WITH STATLOCK & APA)
• 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: 21982907
• Report Number: 2248146-2025-0000265
• Device Sequence Number: 20952304
• Product Code: DSP
• UDI-Device Identifier: 10607567108018
• UDI-Public: (01)10607567108018(10)3000429587(17)271030(11)241030
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K133074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2025

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: 0684-00-0296-02
• Device Catalogue Number: 0684-00-0296-02
• Device Lot Number: 3000429587
• 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: 04/24/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown