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

Model Number	0684-00-0480-01C
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event site full name: (b)(6).Event site postal code: (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).: device not returned.
Event or Problem Description
It was reported that after inserting the intra-aortic balloon (iab) and initiating therapy, the customer found the iab would not inflate.They then pulled out the iab and replaced it with a new one.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood found on the exterior of the catheter.A kink was found on the catheter tubing near the y-fitting approximately 76.2cm from the iab tip.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.The iab was placed on the cs300 pump and the iab fully inflated.No alarm sounded from the pump.The evaluation determined a kink in the catheter tubing.It is difficult to determine when or how a kink in the catheter occurs.Although we did not repeat the event in the laboratory setting, a kink can cause inflation difficulty or an alarm.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. 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: 15322977
• Report Number: 2248146-2022-00668
• Device Sequence Number: 5203826
• Product Code: DSP
• UDI-Device Identifier: 10607567109343
• UDI-Public: 10607567109343
• 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): 01/17/2023

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: 02/21/2025
• Device Model Number: 0684-00-0480-01C
• Device Catalogue Number: 0684-00-0475
• Device Lot Number: 3000223640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2022
• Supplement Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2022
• 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: UNKNOWN.
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 60 KG