MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD MEGA 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0498-07
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after inserting the intra-aortic balloon (iab), it would not inflate properly.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
Event site postal code: (b)(6).Event site telephone: (b)(6).The device was not returned and could not be evaluated.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.Complaint record id # (b)(4).
Event or Problem Description
N/a.
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 product was returned with the membrane completely unfolded and blood found on the exterior of the catheter.The extender tubing was also returned.The inner lumen was observed to be occluded.The occlusion was unable to be cleared.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and no leaks were detected.The iab was placed on the cardiosave pump and the iab fully inflated and deflated.No alarm sounded from the pump.The reported difficult inflation cannot be confirmed 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.Reference complaint # (b)(4).

• Brand Name: MEGA 8FR. 50CC 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: 16708372
• Report Number: 2248146-2023-00247
• Device Sequence Number: 3628488
• Product Code: DSP
• UDI-Device Identifier: 10607567109756
• UDI-Public: 10607567109756
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K091449
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/15/2024

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: 06/05/2025
• Device Model Number: 0684-00-0498-07
• Device Catalogue Number: 0684-00-0497
• Device Lot Number: 3000247117
• 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: 03/20/2023
• Supplement Date Received by Manufacturer: 06/15/2023; 01/15/2024
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 06/15/2023; 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2022
• 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