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	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete event site name: (b)(6) hospital.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 after inserting the intra-aortic balloon (iab), the physician had a question about the radiopaque tip and what lies beyond the distal tip on the iab.He described seeing what appeared to be a "shadow" beyond the tip and was concerned that there might be an issue with the iab.A facetime call was made to see the fleuro screen and the getinge representative was able to observe the darker radiopaque tip.The getinge representative also saw a lighter shade beyond the tip that appeared to be in the same shape and diameter.It was advised that there was a small piece beyond radiopaque tip that concludes the distal end, but it was not radiopaque and that "shading" beyond the tip was not something often seen.Several minutes later, the physician called back to report that they had opened another mega 40cc iab and placed it under fleuroscopy before inserting into the patient.They saw the same darkened shadow beyond the distal radiopaque tip and felt more comfortable that the first iab was okay to use and decided to leave it in the patient.They also questioned at that point if their fleuro device was causing the issue.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
Additional information: describe event or problem.Initial reporter full name: dr.(b)(6).Device evaluation: the product was returned with the membrane completely unfolded and traces of blood on the exterior of the catheter and between the catheter and the sheath.The returned sheath was over the catheter and partially covering the rear portion of the balloon.A kink was found on the catheter tubing approximately 34.8cm from iab tip.Visual examination confirmed that both tip and rear markers were in place per specification.The returned device was inspected and found to have tantalum markers in place per specification.We are unable to determine the cause of the reported complaint since we cannot mimic the clinical setting or patient anatomy.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).
Event or Problem Description
It was reported that after inserting the intra-aortic balloon (iab), the physician had a question about the radiopaque tip and what lies beyond the distal tip on the iab.He described seeing what appeared to be a "shadow" beyond the tip and was concerned that that there might be an issue with the iab.A facetime call was made to see the fleuro screen and the getinge representative was able to observe the darker radiopaque tip.The getinge representative also saw a lighter shade beyond the tip that appeared to be in the same shape and diameter.It was advised that there was a small piece beyond radiopaque tip that concludes the distal end, but it was not radiopaque and that "shading" beyond the tip was not something often seen.Several minutes later, the physician called back to report that they had opened another mega 40cc iab and placed it under fleuroscopy before inserting into the patient.They saw the same darkened shadow beyond the distal radiopaque tip and felt more comfortable that the first iab was okay to use and decided to leave it in the patient.They also questioned at that point if their fleuro device was causing the issue.The iab was in use for approximately seven days.There was no patient harm or adverse event reported.

• 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: 17356582
• Report Number: 2248146-2023-00459
• Device Sequence Number: 6016849
• Product Code: DSP
• UDI-Device Identifier: 10607567107974
• UDI-Public: 10607567107974
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2023

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: 0684-00-0293
• Device Lot Number: 3000282645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 07/19/2023
• Supplement Report FDA Received Date: 08/08/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 117 KG