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	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during intra-aortic balloon (iab) therapy, the console generated a catheter restriction alarm post-op.The customer completed a chest film and they believed the iab was in the correct position.The console was switched out but the same issue occurred.Pumping was continued.They had the augmentation control dialed to "70 percent" and it had not alarmed again, but their augmentation was only in the 60s.Systolic blood pressure (bp) was in the 90s and it was noted that the patient was on multiple vasopressors.They were advised to confirm that the location was good.There was no blood or visible kinks in the helium tubing.The patient was ventilated, sedated, and not moving.They were then advised to try going back up slowly with the augmentation control and the console generated the same alarm immediately at this.The "fill" key would not resume pumping.They tried log rolling the patient without success.The augmentation was dialed back down and they were able to resume pumping.They spoke with the physicians about the issue and were discussing removal and possible replacement.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
Occupation: nurse manager; additional reporter: (b)(6);, rn; 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).
Additional Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood on the interior and 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 portion of the extracorporeal tubing and male leur was cut from the iab and not returned.A kink was found on the catheter tubing and iner lumen near the y-fitting approximately 76.7cm from the iab tip.A kink was found on the catheter tubing approximately 32.3cm from the iab tip.An underwater leak test of the balloon, catheter, y-fitting and portion of extracorporeal tubing was performed and a leak was detected on the membrane approximately 1.8cm from the rear seal measuring 0.013cm in length.The reported problem was most likely triggered by a leak which was found on the membrane.Under magnification, a whitish patch was observed around the leak.This whitish patch is the typical appearance of an abrasion mark which is caused by calcified plaque in the aorta.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 approximately 63 hours and 40 minutes of intra-aortic balloon (iab) therapy, the console generated a catheter restriction alarm post-op at 4:40am.The customer completed a chest film and they believed the iab was in the correct position.The console was switched out but the same issue occurred.Pumping was continued.They had the augmentation control dialed to "70 percent" and it had not alarmed again, but their augmentation was only in the 60s.Systolic blood pressure (bp) was in the 90s and it was noted that the patient was on multiple vasopressors.They were advised to confirm that the location was good.There was no blood or visible kinks in the helium tubing.The patient was ventilated, sedated, and not moving.They were then advised to try going back up slowly with the augmentation control and the console generated the same alarm immediately at this.The "fill" key would not resume pumping.They tried log rolling the patient without success.The augmentation was dialed back down and they were able to resume pumping.They spoke with the physicians about the issue and were discussing removal and possible replacement.The iab was later removed at 6:45am.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
Updated field(s): describe event or problem.Other relevant history.Event site email.

• 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: 17106627
• Report Number: 2248146-2023-00379
• Device Sequence Number: 2805103
• Product Code: DSP
• UDI-Device Identifier: 10607567107974
• UDI-Public: 10607567107974
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Nurse
• Type of Report: Initial,Followup,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: 05/23/2025
• Device Model Number: 0684-00-0295-01
• Device Catalogue Number: 0684-00-0293
• Device Lot Number: 3000244401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2023
• Supplement Date Received by Manufacturer: 07/06/2023; 07/27/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 07/25/2023; 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2022
• 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 IABP.
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 70 KG