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	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 2 days of intra-aortic balloon(iab) therapy, blood was seen in the tubing.The iab was removed and lumen was found to be broken.There was no reported injury or adverse event to the patient.
Additional Manufacturer Narrative
Updated fields: b4, d10, g4, h3, h6, h10.The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.Complaint record id (b)(4).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The product was returned with the membrane completely unfolded with blood on the interior and exterior of the catheter and between the catheter and the sheath.The returned sheath was not a maquet product.The extender tubing was also returned.A visual examination of the product detected the inner lumen within the membrane was completely separated within a kink approximately 24.6cm from iab tip.The inner lumen was found occluded with dried blood.The occlusion was unable to be cleared.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and no other leaks were detected.The break found in the inner lumen appears to have been the result of a severe kink, which eventually failed causing reported problems.It is difficult to determine when the break occurred but it is possibly a result of patient movement during the procedure.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).

• 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: 13457469
• Report Number: 2248146-2022-00092
• Device Sequence Number: 4675416
• 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: Nurse Practitioner
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/02/2022

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: 05/31/2024
• Device Model Number: 0684-00-0479-01C
• Device Catalogue Number: 0684-00-0474
• Device Lot Number: 3000174171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2022
• Supplement Date Received by Manufacturer: 02/25/2022; 06/02/2022
• Initial Report FDA Received Date: 02/04/2022
• Supplement Report FDA Received Date: 03/10/2022; 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2021
• 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: UNKNOWN.
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 58 KG