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 Codes	Inappropriate Waveform (2536); Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after inserting the intra-aortic balloon (iab), the arterial pressure waveform was not displayed.It was noted that the cardiosave intra-aortic balloon pump (iabp) generated a no trigger alarm.The customer exchanged and connected the iab to a different cardiosave iabp, but the issue persisted.The iab was then replaced with a new one, but the same problem occurred again.The iabp was switched again with another cardiosave but this did not resolve the issue.The second iab was also removed.Since the patient was stable, no further iabs were inserted.There was no patient harm or adverse event reported.This report is for the 2nd iab used.A separate report has been submitted for the 1st iab under mfg report number 2248146-2023-00239.
Additional Manufacturer Narrative
Initial reporter occupation: cath lab nurse.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).
Additional Manufacturer Narrative
The product was returned with the membrane completely unfolded and traces of blood on the exterior of the catheter.A kink was found on the catheter tubing and inner lumen near the y-fitting approximately 75.9cm from the iab tip.The technician attempted to insert a laboratory 0.025¿ guidewire through the inner lumen and resistance was only felt at the kinked location of 75.9cm.The condition of the iab as received indicated a kink on the inner lumen and catheter tubing.A kink in the inner lumen can cause difficulty monitoring the pressure waveform.We are unable to determine when the kink may have occurred.The evaluation confirmed the reported problem.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 arterial pressure waveform was not displayed.It was noted that the cardiosave intra-aortic balloon pump (iabp) generated a no trigger alarm.The customer exchanged and connected the iab to a different cardiosave iabp, but the issue persisted.The iab was then replaced with a new one, but the same problem occurred again.The iabp was switched again with another cardiosave but this did not resolve the issue.The second iab was also removed.Since the patient was stable, no further iabs were inserted.There was no patient harm or adverse event reported.This report is for the 2nd iab used.A separate report has been submitted for the 1st iab under mfg report number 2248146-2023-00239.

• 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: 16706619
• Report Number: 2248146-2023-00240
• Device Sequence Number: 17047541
• Product Code: DSP
• UDI-Device Identifier: 10607567107974
• UDI-Public: 10607567107974
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2023

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: 03/22/2025
• Device Model Number: 0684-00-0295-01
• Device Catalogue Number: 0684-00-0293
• Device Lot Number: 3000219437
• 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: 03/17/2023
• Supplement Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2022
• 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: CARDIOSAVE HYBRID.
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 85 KG