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

Model Number	0684-00-0480-01
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354); Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character restrictions in e1: the full initial reporter's name is (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 during intra aortic balloon (iab) therapy there was blood seen in the helium tubing.The iab had been indwelling for 35 days.The iab was replaced with another iab.There was no harm or change in patient status due to this issue.
Additional Manufacturer Narrative
Updated fields: b4; b7; d9; g3; g6; h2; h3; h6 type of investigation, investigation findings, investigation conclusion, problem code; h11 corrected fields: d7a; d10; g1 contact person ¿ mfg site the product was returned with the membrane completely unfolded.Blood was observed on the exterior of the iab, between catheter and sheath, inside the inner lumen, extender tubing and extracorporeal tubing.The returned 7.5fr sheath was returned covering the catheter tubing.Five kinks were noticed on the catheter tubing approximately 76.2cm, 70cm, 69.6cm, 68.8cm and 68.3cm from the iab tip.The iab device was returned in two separate pieces, having been cut/torn at the catheter tubing.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal tubing and extender tubing was performed, and one leak was found in the inner lumen within the catheter tubing, near the y-fitting.The evaluation confirms the reported failure of a leak.It seems that the inner lumen break was found within a sever catheter tubing kink that could have contributed to the separation, however we are unable to determine when this may have 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 reported failure.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses the reported failure.There were no ncmrs identified which could cause or contribute to the reported failure.The investigation does not indicate that the device was inadvertently released as non-conforming or an adulterated product or was a counterfeit.The complaint history review did not identify an adverse trend (increase in number of complaints over past three (3) months).Based on the rational provided above, no escalation to the capa process is required.The evaluation confirms the reported failure of a leak.It seems that the inner lumen break was found within a sever catheter tubing kink that could have contributed to the separation, however we are unable to determine when this may have 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 reported failure.

• Brand Name: LINEAR 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: ewelina chorlowska ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 22507958
• Report Number: 2248146-2025-0000376
• Device Sequence Number: 9265381
• Product Code: DSP
• UDI-Device Identifier: 10607567106564
• UDI-Public: (01)10607567106564(10)3000407611(17)270724(11)240724
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2025

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 Model Number: 0684-00-0480-01
• Device Catalogue Number: 0684-00-0480-01
• Device Lot Number: 3000407611
• 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: 06/30/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2024
• 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, CS300.; UNKNOWN.
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 87 KG