MAUDE Adverse Event Report: DATASCOPE CORP. LINEAR 7.5FR. 25CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0478-01
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete initial reporter name: (b)(6).The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.Complaint record id #: (b)(4).
Event or Problem Description
It was reported that an intra-aortic balloon (iab) leak occurred during therapy.A new iab was inserted to continue therapy.The iab had been inserted on 08november2023.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
A portion of the catheter tubing and membrane was returned completely unfolded with blood on the interior and exterior of the catheter.The sheath was over the catheter and partially covering the rear portion of the membrane.The returned sheath was not a maquet product.A kink was observed on the inner lumen within the membrane approximately 8.9cm 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 and catheter tubing was performed and a leak was detected on the membrane approximately 4.1cm from the rear seal measuring 0.025cm in length.The reported problem was most likely triggered by a leak which was found on the membrane.The penetration found on the membrane appears to have been caused by a sharp object.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 problem 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
It was reported that an intra-aortic balloon (iab) leak occurred during therapy.A new iab was inserted to continue therapy.The iab had been inserted on (b)(6) 2023.The insertion was reported to be axillary, which is not a method described in the instructions for use (ifu).There was no patient harm or adverse event reported.
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: LINEAR 7.5FR. 25CC 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: 18576041
• Report Number: 2248146-2024-00046
• Device Sequence Number: 20778392
• Product Code: DSP
• UDI-Device Identifier: 10607567106526
• UDI-Public: (01)10607567106526(10)3000302508(17)260307(11)230308
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/10/2024

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: 03/07/2026
• Device Model Number: 0684-00-0478-01
• Device Catalogue Number: 0684-00-0478-01
• Device Lot Number: 3000302508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2024
• Supplement Date Received by Manufacturer: 02/22/2024; 10/10/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 02/23/2024; 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2023
• 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: CARDIOSAVE
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 102 KG