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

Model Number	0684-00-0470-01C
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete event site 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).
Event or Problem Description
It was reported that when the intra-aortic balloon (iab) was removed from the t-handle packaging, the membrane was unfurled.Therapy was not initiated.The patient was treated with medication instead.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
Event site telephone number (b)(6).The product was returned with the membrane completely unfolded and traces of blood on the exterior.The one-way valve was not returned for evaluation.A laboratory insertion test was unable to be performed due to the membrane being unfurled.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.A leak may impact the ability to maintain vacuum.We are unable to confirm the reported difficulty during insertion because of the returned condition of the catheter and we are unable to mimic the clinical setting.Per ifu the one-way valve must be aspirated to 30cc while leaving the one-way valve in place attached to the extracorporeal tubing leur to ensure vacuum is maintained throughout insertion.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: 16017978
• Report Number: 2248146-2022-00991
• Device Sequence Number: 6656261
• Product Code: DSP
• UDI-Device Identifier: 10607567109374
• UDI-Public: 10607567109374
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 02/28/2023

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: 03/13/2023
• Device Model Number: 0684-00-0470-01C
• Device Catalogue Number: 0684-00-0434
• Device Lot Number: 3000116946
• 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: 11/28/2022
• Supplement Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 56 KG