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

Model Number	0684-00-0295-01
Medical Device Problem Code	Inability to Auto-Fill (1044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter full name:(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 during intra-aortic balloon (iab) therapy, natalie had a patient on a iabp that was alarming "autofill failure".Natalie said that they decided to remove the iab.There was no blood in the helium tubing, and they felt the catheter was likely kinked or moved.They would replace the iab.The insertion was reported to be axillary, which is not the method described in the device instructions for use.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation.Reference complaint #(b)(4).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The iab was returned with the membrane completely unfolded and blood on the interior and exterior of the inner lumen.One kink was observed on both the inner lumen and catheter tubing approximately 76.2cm from the iab tip.The three-way stopcock was also returned.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and a leak was detected on the catheter tubing approximately 54.6cm from the iab tip.The evaluation determined a catheter tubing penetration, confirming the failure reported.It is difficult to determine when or how this occurred.The leak size suggests that a sharp object may have caused it, no marks were found around the leak.The insertion was reported to be axillary, which is not the method described in the device instructions for use.This may have contributed to the iab failure.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 (3) months).Based on the rational provided above, no escalation to the capa process is required.Reference complaint # (b)(4).

• Brand Name: MEGA 7.5FR. 40CC 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: 20570243
• Report Number: 2248146-2024-0000664
• Device Sequence Number: 12627366
• Product Code: DSP
• UDI-Device Identifier: 10607567107974
• UDI-Public: (01)10607567107974(10)3000282645(17)251127(11)221128
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K120868
• 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,Followup
• Report Date (Section B): 01/23/2025

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: 11/27/2025
• Device Model Number: 0684-00-0295-01
• Device Catalogue Number: 0684-00-0295-01
• Device Lot Number: 3000282645
• 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: 10/10/2024
• Supplement Date Received by Manufacturer: 11/21/2024; 01/22/2025
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 11/21/2024; 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 69 KG