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

Model Number	0684-00-0479-01U
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.(b)(4).
Event or Problem Description
It was reported that immediately upon insertion of the intra-aortic balloon (iab), it would not inflate properly.It was noted that the proximal portion of the iab had inflated but the distal portion did not.After multiple attempts and troubleshooting, the iab was removed and a new one was inserted successfully to continue therapy.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
The product was returned with the membrane completely unfolded with blood on the exterior.A sheath was not returned.Two catheter tubing kinks were observed approximately 71.88cm & 76.45cm from the iab tip.An underwater leak test of the balloon, catheter, y-fitting, extender tubing, and extracorporeal tubing was performed and no leaks were performed.The iab was placed on the cs300 pump and pumped for two hours which represents one complete autofill cycle.The iab pumped normally and no alarm sounded from the pump.The reported event cannot be confirmed by the evaluation.A non-conforming material report 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. 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: 12951175
• Report Number: 2248146-2021-00830
• Device Sequence Number: 11962967
• Product Code: DSP
• UDI-Device Identifier: 10607567109503
• UDI-Public: 10607567109503
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K041281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2023

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: 09/17/2023
• Device Model Number: 0684-00-0479-01U
• Device Catalogue Number: 0684-00-0474
• Device Lot Number: 3000131707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2021
• Supplement Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 77 KG