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 Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter full name: (b)(6).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 the customer attempted a sheath-less insertion of the intra-aortic balloon (iab) and found blood inside the central lumen.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
Additional information: describe event or problem, other relevant history, device available for eval?, event site telephone.Reference complaint # (b)(4).
Event or Problem Description
It was reported that the customer attempted a sheath-less insertion of the intra-aortic balloon (iab) and found blood inside the central lumen and helium gas tube.Also, there was a reported helium leak alarm.The iab was replaced and therapy continued.There was no patient harm or adverse event reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation.Reference complaint #(b)(4).

• 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: 15663562
• Report Number: 2248146-2022-00831
• Device Sequence Number: 15070484
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/01/2023

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: 11/16/2023
• Device Model Number: 0684-00-0470-07
• Device Catalogue Number: 0684-00-0434
• Device Lot Number: 3000137245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2022
• Supplement Date Received by Manufacturer: 11/02/2022; 03/01/2023
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 11/16/2022; 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/16/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Unknown
• Patient Weight: 69 KG