MAUDE Adverse Event Report: DATASCOPE CORP. LINEAR 7.5FR. 34CC IAB (WITH APA); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0479-02
Medical Device Problem Codes	Inflation Problem (1310); Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that initially the labels inside and outside the box of the balloon catheter intra-aortic balloon (iab) did not match.However, it was later clarified that there was no labelling issue; instead, the problem was with the catheter itself.No harm to the patient reported.
Additional Manufacturer Narrative
Updated field: b4, d4 lot#, udi #, expiry date, d9, g3, g6, h2, h3, h6 (type of investigation, investigation conclusions), h11.Corrected field: d1, d4 version/model#, catalog#.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 id# (b)(4).
Additional Manufacturer Narrative
Udi related data quality updates only.Providing updated device identification information in alignment with gudid.
Additional Manufacturer Narrative
Updated fields: b4, d8, d9, e1, g3, g6, h3, h6 (type of investigation, investigation findings, component codes, investigation conclusions), h11.The iab was returned with the membrane completely unfolded and blood on the exterior of the catheter.The extender tubing was also returned.The technician attempted to insert a laboratory 0.025¿ guide wire through the inner lumen of the returned iab and found that the inner lumen was occluded.The technician was unable to clear the occlusion; however, evidence of dried blood was observed at the tip of the guide wire.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and no leaks were detected.The iab was placed on the cardiosave pump and the iab fully inflated.No alarm sounded from the pump.The condition of the iab as received indicated an occlusion in the inner lumen.An occlusion can cause difficulty monitoring the pressure.We were unable to confirm difficult inflation of the iab.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Complaint id# (b)(4).

• Brand Name: LINEAR 7.5FR. 34CC IAB (WITH APA)
• 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: 21383435
• Report Number: 2248146-2025-0000078
• Device Sequence Number: 18211157
• Product Code: DSP
• UDI-Device Identifier: 10607567106557
• UDI-Public: (01)10607567106557(10)3000307165(17)260509(11)230509
• Combination Product (Y/N): N
• Initial Reporter Country: CY
• PMA/510(K) Number: K041281
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/09/2025

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: 05/09/2026
• Device Model Number: 0684-00-0479-02
• Device Catalogue Number: 0684-00-0479-02
• Device Lot Number: 3000307165
• 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: 01/29/2025
• Supplement Date Received by Manufacturer: 03/20/2025; 03/28/2025; 05/08/2025
• Initial Report FDA Received Date: 02/14/2025
• Supplement Report FDA Received Date: 03/21/2025; 03/28/2025; 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 100 KG