MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0479-01C
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The device will not be 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 intra-aortic balloon (iab) was used with another manufacturer's console, however, the customer did not use the provided adapter.Therefore, the console could not recognize the iab.The customer mistook this as the iab malfunctioning.There was no iab malfunction, patient harm, or adverse event reported.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation.Analysis of production (3331/213) - the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis (4109/213) - the review of the historical data was performed.Trend analysis (4110/213) - the overall complaint trend data for the period nov-2019 through oct-2021 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint # (b)(4).
Event or Problem Description
N/a.

• Brand Name: LINEAR 7.5 FR. 34CC 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: 12728061
• Report Number: 2248146-2021-00715
• Device Sequence Number: 16510873
• Product Code: DSP
• UDI-Device Identifier: 10607567109329
• UDI-Public: 10607567109329
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2021

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: 03/04/2023
• Device Model Number: 0684-00-0479-01C
• Device Catalogue Number: 0684-00-0474
• Device Lot Number: 3000115982
• 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: 10/13/2021
• Supplement Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 11/01/2021
• Supplement Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2020
• 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: ARROW PUMP; ARROW PUMP
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Weight: 80 KG