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	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that under imaging, one radiopaque marker on the intra-aortic balloon (iab) appeared to be missing.This occurred after two days of therapy.It was also noted that an autofill failure alarm was generated.The insertion was reported to be axillary, which is not the method described in the device instructions for use.The customer was unable to troubleshoot but the console and iab function were otherwise appropriate, and the bedside team deferred replacing the catheter and left the current iab in use.The iab was then removed of three days of use.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
Occupation: dnp, rn-bc, patient care manager.The product has been returned to the manufacturer but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.Complaint record id (b)(4).
Additional Manufacturer Narrative
Updated fields: b4, d9, g1 (contact person ¿ mfg site), g3, g6, g7, h2, h3, h6 (investigation findings, type of investigation, investigation conclusions), h11.No decon or visual inspection performed since product was not returned and could not be evaluated.Based on the provided x-ray we were unable to visualize the proximal nor the distal marker along the length of the iab catheter that may suggest marker migration.The insertion was reported to be axillary, which is not the method described in the device instructions for use.This may have contribute to iab catheter complications.Efforts were made to get additional x-ray photos and information on the event but no response was received.We are unable to confirm the reported problems due to the device not being returned as well as the insufficiently defined x-ray film.If the device becomes available for return, a new evaluation letter will be provided.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Complaint id no.: (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: 20582245
• Report Number: 2248146-2024-0000667
• Device Sequence Number: 8171157
• Product Code: DSP
• UDI-Device Identifier: 10607567107974
• UDI-Public: (01)10607567107974(10)3000282645(17)251127(11)221118
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2025

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?: No
• Date Returned to Manufacturer: 10/30/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2024
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 78 KG