MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0470-07
Medical Device Problem Codes	Inability to Auto-Fill (1044); Inflation Problem (1310); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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).
Event or Problem Description
It was reported that after insertion, the console generated an autofill failure alarm and the intra-aortic balloon (iab) was not able to inflate.The customer found a kink in middle of the iab.A new iab was inserted to continue therapy.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
No decon or visual inspection performed since product was not returned and could not be evaluated.The video from the facility shows the iab difficult/unable to inflate.Blood is observed on the balloon membrane exterior.A kink was observed in the middle of the balloon.The provided pictures and video confirm the reported problems.We are unable to determine when they may have occurred.Reference complaint #(b)(4).
Additional Manufacturer Narrative
A video and photograph were provided by the facility.Blood is visible on the iab catheter.The iab is observed to be partially folded.No kinks are visible in the material provided.The product was returned with the membrane partially unfolded and blood on the exterior of the catheter.A kink was found on the catheter near the y-fitting approximately 75.9cm from the iab tip.The inner lumen was observed to be occluded.The occlusion was unable to be cleared.An underwater leak test of the balloon, catheter, y-fitting, and extracorporeal tubing was performed and no leaks were detected.The iab was placed on the cardiosave pump and the iab fully inflated and deflated.The iab then pumped for two hours which represents one complete autofill cycle.The iab pumped normally and no alarm sounded from the pump.The condition of the iab as received indicated a kink in the catheter tubing.It is difficult to determine when or how a kink in the catheter occurs.The evaluation confirmed the reported kink however the reported alarm and inflation difficulties cannot be confirmed by the evaluation.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: SENSATION 7FR. 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: 17309521
• Report Number: 2248146-2023-00433
• Device Sequence Number: 20659934
• Product Code: DSP
• UDI-Device Identifier: 10607567109749
• UDI-Public: 10607567109749
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K063525
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/18/2024

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: 02/15/2026
• Device Model Number: 0684-00-0470-07
• Device Catalogue Number: 0684-00-0434
• Device Lot Number: 3000293912
• 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: 06/19/2023
• Supplement Date Received by Manufacturer: 08/29/2023; 01/18/2024
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 08/30/2023; 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2023
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 67 KG