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

Catalog Number	0684-00-0293
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter full name: (b)(6).Event site postal code: (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 when opening the intra-aortic balloon (iab) packaging, the customer two insertion kits.The actual iab tray was missing from the packaging.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
No decon or visual inspection performed since product was not returned and could not be evaluated.However, four photographs were provided by the facility with the iab kit they have received.We are unable to confirm the reported failure because parts were not sent back and for the evidence mentioned above.The iab kit might have been misplaced during the preparations of the surgery.Reference complaint #(b)(4).
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
A mega 7.5fr 40cc shelf carton was returned opened with two sealed and intact insertion kits.The iab kit was missing from the shelf carton.Photos were also provided and reviewed with the same observations.The reported event was confirmed by the evaluation.However, were unable to determine a root cause of how this occurred as our records do not indicate missing components for the batch.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.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. - 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: 17038109
• Report Number: 2248146-2023-00363
• Device Sequence Number: 15211381
• Product Code: DSP
• UDI-Device Identifier: 10607567111339
• UDI-Public: 10607567111339
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K120868
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2024

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: 02/03/2026
• Device Catalogue Number: 0684-00-0293
• Device Lot Number: 3000288265
• 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: 05/12/2023
• Supplement Date Received by Manufacturer: 08/31/2023; 03/13/2024
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 08/31/2023; 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2023
• 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.
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 70 KG