MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0480-02
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that immediately after inserting the intra-aortic balloon (iab), the pump generated a twisted catheter alarm every 20 minutes.It was noted that another manufacturer's pump was being used.Pumping was paused, forcing the operators to turn off the alarm and manually restart the iab.It was noted that under the fluoroscopic control, no image compatible with kinking or twisting of the iab was found, which it was therefore decided to leave the iab in place.The iab was removed after two days of therapy.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
Initial reporter full name: (b)(6) additional initial reporter: (b)(6) event site name: (b)(6) event site postal code: (b)(6) the device was not returned and could not be evaluated.It will not be returned for investigation.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.Complaint record id # (b)(4).H3 other text : device not returned.
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: LINEAR 7.5 FR. 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: 17342845
• Report Number: 2248146-2023-00455
• Device Sequence Number: 6496709
• Product Code: DSP
• UDI-Device Identifier: 10607567106571
• UDI-Public: 10607567106571
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 08/16/2023

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: 11/27/2025
• Device Model Number: 0684-00-0480-02
• Device Catalogue Number: 0684-00-0475
• Device Lot Number: 3000282637
• 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: 06/29/2023
• Supplement Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/28/2022
• 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: AUTOCAT2WAVE ARROW PUMP
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 75 KG