MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 25CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0478-01
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during intra-aortic balloon (iab) therapy, (b)(6) called from the micu to report the "unable to update timing" message on the pump.She said it had been on for quite some time.She reported that the patient was very stable, awaiting a transplant and the iab was in the axillary position, which is not the method described in the device instructions for use.A texted screenshot of the waveform showed a clean arterial waveform without artifact, but without a clear dicrotic notch and without clear landmarks.The iab pressure waveform was rounded in appearance without any semblance of a chair pattern.Ecg was normal sinus rhythm (nsr) in the 80s.They had attempted aspirating and flushing the central lumen.She stated that the physicians were satisfied with iab location, and were not concerned about the message as the patient was stable.We advised (b)(6) that she could move to semi auto, but she was hesitant due to the need for an order from the md to do so.Also suggested moving the aline to a separate site if it was available.There was no other aline, and she stated that they would likely not insert an aline for that reason.Offered to assist her further if they choose to try either of the options and she would call back if needed.She felt that with the patient's stability she was comfortable leaving the timing message alone.There was no reported injury or adverse event to the patient.
Additional Manufacturer Narrative
Initial reporter complete name: (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 iab was returned with the membrane completely unfolded and blood on the exterior and interior of the catheter.A portion of the extracorporeal tubing and male leur was cut from the iab and not returned.The inner lumen was found occluded with dried blood.The occlusion was unable to be cleared.A visual examination of the product detected a penetration on the catheter tubing within a kink on the catheter tubing and inner lumen near the y-fitting approximately 76.5cm from iab tip.An underwater leak test of the balloon, catheter, y-fitting and portion of extracorporeal tubing was performed and no other leaks were detected.We were unable to confirm the reported failure alarm, unable to update timing because the failure mode is related to an intra-aortic balloon pump and not the iab catheter.The penetration found in the catheter tubing appears to have been caused by a severe kink flexing back and forth that eventually penetrated the tubing.The insertion was reported to be axillary, which is not the method described in the device instructions for use.This may have contributed to the iab catheter failure.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
N/a.

• Brand Name: LINEAR 7.5 FR. 25CC 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: 16008773
• Report Number: 2248146-2022-00981
• Device Sequence Number: 6655638
• Product Code: DSP
• UDI-Device Identifier: 10607567106526
• UDI-Public: 10607567106526
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K041281
• 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
• Report Date (Section B): 04/04/2023

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: 05/03/2024
• Device Model Number: 0684-00-0478-01
• Device Catalogue Number: 0684-00-0473
• Device Lot Number: 3000168822
• 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: 12/05/2022
• Supplement Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2021
• 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: 33 YR
• Patient Sex: Female
• Patient Weight: 67 KG