MAUDE Adverse Event Report: DATASCOPE CORP. TRANSRAY 34CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0469-01
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 id: (b)(4).
Event or Problem Description
It was reported during use that intra-aortic balloon(iab) tr3455 was inserted and operated at around 12:00 on (b)(6) 2025, but a gas loss alarm sounded at around 16:00 on the same day.When the catheter extension tube was checked, blood was found, and balloon rupture was suspected, so operation was stopped.
Additional Manufacturer Narrative
Updated fields: h6 (type of investigation, investigation findings, component codes, investigation conclusions, health effect ¿ clinical code, health effect ¿ impact codes).Corrected fields: d4 (lot no, udi no.).The product was returned with the membrane completely unfolded and blood on the interior of the catheter and the interior.A kink was observed on the catheter tubing approximately 76.2cm from the iab tip.The extender tubing and three-way stopcock were also returned.The innerlumen was found to be occluded.The occlusion was unable to be cleared.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal tubing and extender tubing was performed and a leak was detected on the membrane approximately 23cm from the iab tip measuring 0.005cm in length.The evaluation confirmed the reported failures.The reported problems were most likely triggered by a leak which was found on the membrane.Under magnification, a whitish patch was observed around the leak.This whitish patch is the typical appearance of an abrasion mark which is caused by calcified plaque in the aorta.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 evaluation confirmed the reported failures.The reported problems were most likely triggered by a leak which was found on the membrane.Under magnification, a whitish patch was observed around the leak.This whitish patch is the typical appearance of an abrasion mark which is caused by calcified plaque in the aorta.Complaint id: (b)(4).
Event or Problem Description
It was reported during use that intra-aortic balloon(iab) tr3455 was inserted and operated at around 12:00 on (b)(6) 2025, but a gas loss alarm sounded at around 16:00 on the same day.When the catheter extension tube was checked, blood was found, and balloon rupture was suspected, so operation was stopped.There was no injury or harm reported to the patient.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields - b4, g3, g6, h2, h6, h11.The product was returned with the membrane completely unfolded and blood was found on the interior of the catheter and the exterior.A kink was observed on the catheter tubing approximately 76.2cm from the iab tip.The extender tubing and three-way stopcock were also returned.The inner-lumen was found to be occluded.The occlusion was unable to be cleared.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal tubing and extender tubing was performed and a leak was detected on the membrane approximately 23cm from the iab tip measuring 0.005in / 0.0127cm in length.The evaluation confirmed the reported failures.The reported problems were most likely triggered by a leak which was found on the membrane.Under magnification, a whitish patch was observed around the leak.This whitish patch is the typical appearance of an abrasion mark which is caused by calcified plaque in the aorta.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.

• Brand Name: TRANSRAY 34CC
• 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: lori gosselin ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 21546206
• Report Number: 2248146-2025-0000124
• Device Sequence Number: 7735690
• Product Code: DSP
• UDI-Device Identifier: 10607567106755
• UDI-Public: (01)10607567106755(17)261113(10)3000347920(11)231113
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/15/2025

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: 0684-00-0469-01
• Device Catalogue Number: 0684-00-0469-01
• Device Lot Number: 3000347920
• 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: 02/18/2025
• Supplement Date Received by Manufacturer: 05/02/2025; 07/03/2025; 07/15/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 05/05/2025; 07/09/2025; 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2023
• 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 HYBRID, 3.1 EDITION IABP
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 61 KG