MAUDE Adverse Event Report: DATASCOPE CORP. TRANS-RAY 7FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0545-01
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during therapy, an intra-aortic balloon (iab) rupture occurred while the patient underwent an operation.The iab was removed after approximately one day of use.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
Event site postal code: (b)(6).This event occurred on the japanese market with a transray 34cc iab, which is a significantly similar device to sensation 34cc which is sold in the us.For d4: di number has been used for sensation 34cc or (01)10607567106755, which is sold in the usa.Provided d4 lot number, d4 expiration date, and h4 device manufacture date corresponding to transray device involved in the event, which is not available in usa.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
N/a.
Additional Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter and between catheter and sheath.The maquet sheath was returned covering the catheter tubing.The extender tubing was returned cut.The three-way stopcock and extender tubing was also returned.A fiber optic break was found 18.3 cm from the iab tip.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 1.01 cm from the rear seal measuring 0.025 cm length.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 non-conformances were found that are considered to be related to the event.No decon or visual inspection performed since product was not returned and could not be evaluated.Therefore, we were unable to confirm or determine a root cause for the reported failure.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.Complaint #(b)(4).

• Brand Name: TRANS-RAY 7FR. 34CC 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: henry pena ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 20854197
• Report Number: 2248146-2024-0000756
• Device Sequence Number: 8688239
• Product Code: DSP
• UDI-Device Identifier: 10607567106755
• UDI-Public: (01)10607567106755(17)260914(10)3000332999(11)230914
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122628
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2025

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 Expiration Date: 09/14/2026
• Device Model Number: 0684-00-0545-01
• Device Catalogue Number: 0684-00-0545-01
• Device Lot Number: 3000332999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2023
• 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: CS300/SI215441H2
• Patient Sex: Unknown