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	Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2022
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 after approximately one day of intra-aortic balloon (iab) therapy the console generated an unable to calibrate optical sensor alarm.The customer adjusted the iab but received the same alarm.Therapy was continued with the console in ecg trigger.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood on the exterior of the catheter.The extender tubing was returned.The sheath was returned attached approximately 41.6cm from the iab.The inner lumen was found to be occluded with dried blood.The occlusion was unable to be cleared.A sensor output test was performed and a pressure reading could not be obtained.The technician then used an optical light to detect any breaks in the sensor's optical fiber and no breaks were observed along the length of the optical fiber.The evaluation confirmed the reported sensor failure.However, we are unable to determine how this failure may have occurred and has been escalated to respective supplier to determine a root cause.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.
Additional Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood on the exterior of the catheter.The extender tubing was returned.The sheath was returned attached approximately 41.6cm from the iab.The inner lumen was found to be occluded with dried blood.The occlusion was unable to be cleared.A sensor output test was performed and a pressure reading could not be obtained.The technician then used an optical light to detect any breaks in the sensor's optical fiber and no breaks were observed along the length of the optical fiber.The evaluation confirmed the reported sensor failure.The root cause is addressed under scar 21-f-scar-14; in which it was found that the optical fiber was broken inside the connector assembly.Total preventive maintence was implemented for the eddy dispenser to establish a frequency maintenance using maximo platform.Additionally, weighing method improvement was implemented to ensure correct epoxy amount was placed into sensor cable connectors.An additional corrective action was guard installation with automatic motion on eddy dispenser to prevent take out connectors during epoxy injection cycle.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: 16133902
• Report Number: 2248146-2023-00031
• Device Sequence Number: 14284508
• 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,Followup
• Report Date (Section B): 05/01/2024

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: 05/18/2024
• Device Model Number: 0684-00-0470-01C
• Device Catalogue Number: 0684-00-0434
• Device Lot Number: 3000160790
• 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: 12/22/2022
• Supplement Date Received by Manufacturer: 04/05/2023; 04/30/2024
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 04/05/2023; 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 94 KG