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

Model Number	0684-00-0295-01
Medical Device Problem Codes	Leak/Splash (1354); Migration (4003)
Health Effect - Clinical Codes	Hematoma (1884); Pseudoaneurysm (2605)
Date of Event	01/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter: (b)(6), bsc, rrt, rrtaccs/ clinical quality & patient safety coordinator.The device has not been returned to the manufacturer so we are unable to complete an evaluation.Reference complaint #(b)(4).H3 other text : device not returned.
Event or Problem Description
It was reported that during intra-aortic balloon (iab) therapy, the catheter position migrated and was respositioned at the bedside, without using fluoroscopy.The customer stated that the iab migrated again, and they attempted to reposition on early (b)(6) 2024.Kink alars occurred prior, and during, the malposition time frame and with patient movement.A hematoma had developed at the insertion site on (b)(6) 2024 with cardiology and vasular awareness.The customer states that they planned to remove the iab catheter, and repar the hematoma/psuedoaneurysm site, on (b)(6) 2024 at time of left ventricular assist device (lvad) insertion.Iab rupture occurred on (b)(6) 2024 at approximately 11:55am with blood noted approximately 1/3 of the way up the helium line.The intra-aorta balloon pump (iabp) was put on standby and the catheter was removed.The insertion was reported to be axillary, which is not listed in the instructions for use (ifu).
Additional Manufacturer Narrative
Updated fields: lot #, serial #, exp.Date, device available for eval?, manufacture date.Device evaluation: 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 over the catheter but it was not a maquet product.The extender and pressure tubing were also returned.A visual examination of the product detected the inner lumen within the catheter tubing was completely separated within a kink approximately 76.7cm 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, extender and pressure tubing was performed and no other leaks were detected.The evaluation determined a inner lumen break within a catheter kink causing the reported problems.It is difficult to determine when or how this occurred.The insertion was reported to be axillary, which is not the method described in the device instructions for use.This may have contributed to the iab failure.The evaluation confirmed the reported problems.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).
Additional Manufacturer Narrative
Udi related data quality updates only.Providing updated device identification information in alignment with gudid (d1, d2, d3, d4, g4, h4, h5).Reference complaint #(b)(4).
Event or Problem Description
N/a.

• Brand Name: MEGA 7.5FR. 40CC IAB
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE CORP.; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 18687165
• Report Number: 2248146-2024-00085
• Device Sequence Number: 17949261
• Product Code: DSP
• UDI-Device Identifier: 10607567107974
• UDI-Public: (01)10607567107974(10)3000308473(17)260530(11)230530
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K120868
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/30/2026
• Device Model Number: 0684-00-0295-01
• Device Catalogue Number: 0684-00-0295-01
• Device Lot Number: 3000308473
• 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: 01/26/2024
• Supplement Date Received by Manufacturer: 04/16/2024; 10/29/2024
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 04/18/2024; 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2023
• 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.
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 132 KG