MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD MEGA 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number	0684-00-0497
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after two days of intra-aortic balloon (iab) therapy a balloon rupture occurred.The patient was taken to the cath lab to have a new iab inserted.There was no patient harm or adverse event reported.Reported via medwatch # (b)(4): upon noticing audible iabp alarm.L axillary iabp access site noted to have blood along length of the return line tubing.Tubing was clamped proximally with a kelly clamp.Iabp was turned off, and return line disconnected and placed in a biohazard bag for appropriate analysis.After blood was noted in the iabp tubing, pump was turned off and cardiovascular team notified.Patient required a procedure to have the balloon pump exchanged.Cath lab was activated for balloon pump exchange.At the end of the procedure, good function of the iabp catheter was confirmed.
Additional Manufacturer Narrative
Occupation: site manager, materials management.Additional reporter(s): (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).
Additional Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation.Reference complaint: (b)(4).
Event or Problem Description
N/a.

• Brand Name: MEGA 8FR. 50CC 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: 17725526
• Report Number: 2248146-2023-00558
• Device Sequence Number: 7163379
• Product Code: DSP
• UDI-Device Identifier: 10607567109619
• UDI-Public: 10607567109619
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K091449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2023

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: 01/22/2026
• Device Catalogue Number: 0684-00-0497
• Device Lot Number: 3000292350
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2023
• Supplement Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2023
• 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 PUMP.
• Patient Age: 52 YR
• Patient Sex: Male