MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0479-01U
Medical Device Problem Code	Inability to Auto-Fill (1044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after eight days of intra-aortic balloon (iab) therapy, the console generated an iab catheter restriction alarm which eventually developed into an auto-fill failure alarm.They were unable to resume pumping due to the constant alarms.There was no blood in the tubing and there were no visible kinks in the catheter.The insertion was reported to be axillary, which is not the method described in the device instructions for use.The customer attempted a decrease in augmentation control, and attempted pressing "iab fill" key without relief.They were advised to obtain a chest x-ray to check the location and contact the physician for further instruction and possible replacement/removal.It was later reported that the iab had been removed and replaced with a new one.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
(b)(6).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.Complaint record id # (b)(4).
Additional Manufacturer Narrative
The product was returned with the membrane completely unfolded with blood on the exterior.The catheter was cut at approximately 59.18cm from the iab tip.An inner lumen kink was observed at approximately 13.97cm from the iab tip.An underwater leak test of the balloon and catheter was performed and no leaks were detected.A guidewire insertion test found that there was an inner lumen occlusion which could not be cleared.Due to the returned condition of the iab, we could not replicate the laboratory settings to investigate the reported failures.Therefore, the reported complaints cannot be confirmed.A non-conforming material report review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Analysis of production (3331/213) - the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis (4109/213) - the review of the historical data was performed.Trend analysis (4110/213) - the overall complaint trend data for the period dec-2019 through nov-2021 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint # (b)(4).
Event or Problem Description
N/a.

• Brand Name: LINEAR 7.5 FR. 34CC 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: 12916046
• Report Number: 2248146-2021-00807
• Device Sequence Number: 5718605
• Product Code: DSP
• UDI-Device Identifier: 10607567109503
• UDI-Public: 10607567109503
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 03/08/2022

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: 05/31/2024
• Device Model Number: 0684-00-0479-01U
• Device Catalogue Number: 0684-00-0474
• Device Lot Number: 3000174171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2021
• Supplement Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 112 KG