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

Model Number	0684-00-0480-02
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the intra-aortic balloon(iab) to insert to the patient due to hypo tension.During insertion process the guide wire was not able to pass through the tip of the balloon catheter as it was chocked from the tip.No indication of harm.
Event or Problem Description
It was reported that while inserting the intra-aortic balloon (iab) to the patient due to hypo tension, the guide wire was not able to pass through the tip of the balloon catheter as it was chocked from the tip.No indication of harm.
Additional Manufacturer Narrative
Updated fields: b3,b4,g3,g6,h2.H6(type of investigation),h11.Corrected fields: b5,d1,d4(lot #,expiration date,unique device identifier (udi) #),h4.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 record id #(b)(4).
Additional Manufacturer Narrative
Due to character restriction in block e1 e1 event site name is (b)(6).Corrected field : e1 ( event site name , city ) updated field : b4, g3, g6, h2, h11, h6 ( investigation conclusions ).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, d9, g3, g6, h2, h3, h6 (type of investigation, and investigation findings), h11 corrected fields: d4 (serial) and d8 revert these two fields to blank.The iab was returned with the membrane completely unfolded and blood on the exterior of the catheter with the one-way valve attached.The guide wire was not returned for evaluation.The technician attempted to insert a 0.025¿ laboratory guide wire through the inner lumen of the returned iab and found that the inner lumen occluded.The technician was able to clear the occlusion and evidence of dried blood was observed at the tip of the guide wire.The condition of the iab as received indicated an occlusion in the inner lumen.An occlusion can cause difficulty inserting the guidewire into the iab.We are unable to determine how this may have occurred.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.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.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Due to character limitations in e1 event site address - (b)(6), initial reporter - (b)(6).Updated fields - b4, e1(event site address, event site telephone, event site email), g3, g6, h2, h3, h6(health effect ¿ clinical code), h11.Corrected field - d10, h6 (type of investigation).

• Brand Name: LINEAR 7.5FR. 40CC 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: ewelina chorlowska ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 21490885
• Report Number: 2248146-2025-0000096
• Device Sequence Number: 17132918
• Product Code: DSP
• UDI-Device Identifier: 10607567106571
• UDI-Public: (01)10607567106571(10)3000367229(17)270126(11)240126
• Combination Product (Y/N): N
• Initial Reporter Country: PK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/17/2026

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: 0684-00-0480-02
• Device Catalogue Number: 0684-00-0480-02
• Device Lot Number: 3000367229
• 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: 02/11/2025
• Supplement Date Received by Manufacturer: 04/01/2025; 10/03/2025; 01/02/2026; 02/17/2026
• Initial Report FDA Received Date: 02/28/2025
• Supplement Report FDA Received Date: 04/02/2025; 10/03/2025; 01/09/2026; 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2024
• 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: IABP.; UNKNOWN.
• Patient Sex: Unknown