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

Model Number	0684-00-0295-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/10/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
Occupation - mshs, bsn, rn, nha, head of risk management / patient safety officer.Additional reporter: dr.(b)(6).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).
Event or Problem Description
It was reported that during the insertion process of the intra-aortic balloon (iab), the sheath dilator broke off at the hub and ended up in the aorta of the patient.In the retrieval process, the aorta was perforated.The patient later passed away.
Additional Manufacturer Narrative
Updated field(s): patient information, describe event or problem, serial#, other relevant history.Complaint record id#: (b)(4).
Event or Problem Description
It was reported that during the insertion process of the intra-aortic balloon (iab), the sheath dilator broke off at the hub and ended up in the aorta of the patient.In the retrieval process, the aorta was perforated.A new iab was not inserted.The patient later passed away.
Additional Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood found on the exterior of the catheter.The introducer sheath and one-way valve were also returned.Additionally the hub of the introducer dilator was returned without the tubing.The broken tubing of the dilator was not returned.The sheath and dilator hub were measured and found to be dimensionally within specification.The evaluation confirms the reported problem.The dilator hub was detached from the dilator shaft.The root cause of the issue at this time is impossible to define.Capa: 830128 has been initiated to investigate this issue further and identify a root cause.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.
Event or Problem Description
N/a.

• Brand Name: MEGA 7.5FR. 40CC IAB
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ
• MDR Report Key: 16648701
• Report Number: 2248146-2023-00225
• Device Sequence Number: 17693151
• Product Code: DSP
• UDI-Device Identifier: 10607567107974
• UDI-Public: 10607567107974
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/08/2025
• Device Model Number: 0684-00-0295-01
• Device Catalogue Number: 0684-00-0293
• Device Lot Number: 3000279117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2023
• Supplement Date Received by Manufacturer: 04/11/2023; 06/07/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 05/01/2023; 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2025
• 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.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 72 KG