MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 25CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0478-01
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event site full address: (b)(6).The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.Complaint record id # (b)(4).
Event or Problem Description
It was reported that a vapor-like substance inside the intra-aortic balloon (iab) insertion kit was found.There was no patient involvement and no adverse event reported.
Additional Manufacturer Narrative
No decontamination was performed for this product since it was returned in its original packaging and intact.It has not been exposed to any clinical or known biohazardous conditions.The catheter kit and insertion kit were returned intact and sealed.The evaluation consisted of a visual and chemical analysis inspection confirming the presence of fluid inside the packaging.A sample of this fluid has been tested via infrared spectrum analysis and found to be silicone.Intra-aortic balloon catheters and some insertion kit components manufactured by datascope corp.Require medical grade silicone lubricant during manufacturing, and some lubricant may also be used as a surface coating to insure smooth insertion for small french size devices.Thus, it is possible that small spots (ranging from not visible to being visually obvious) of migrated lubricant may appear between the tray and the clear tray cover.This silicone is not foreign matter, is biocompatible and does not affect or compromise sterility of the intra-aortic balloon catheters or insertion kits.The evaluation confirmed the reported problem.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: LINEAR 7.5 FR. 25CC 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: 16371362
• Report Number: 2248146-2023-00102
• Device Sequence Number: 20675265
• Product Code: DSP
• UDI-Device Identifier: 10607567106526
• UDI-Public: 10607567106526
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K041281
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2023

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: 07/12/2024
• Device Model Number: 0684-00-0478-01
• Device Catalogue Number: 0684-00-0473
• Device Lot Number: 3000183035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2023
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown