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

Model Number	0684-00-0480-07
Medical Device Problem Codes	Difficult to Insert (1316); Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event site postal code: (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 intra-aortic balloon (iab) therapy was indicated post-surgery as the patient was hemodynamically unstable.During insertion, it was noted that the guidewire was bent and the iab became kinked.The iab was unable to be inserted.As the patient's blood pressure was deteriorating, a new iab was then inserted to provide therapy.There was no patient harm or adverse event reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation.Reference complaint #(b)(4).
Additional Manufacturer Narrative
Updated fields - b4, d9 return to manufacture date, g3, g6, h2, h6 (type of investigation, investigation findings, investigation conclusions), h11.Corrected field: h3, h6 investigation findings, type of investigation and medical device ¿ problem code.The product was returned with the membrane loosely folded, and no blood was observed on iab.One kink was found on the catheter tubing approximately 76.7cm from the iab tip.The original guidewire was not returned for evaluation.The extender tubing was also returned with the iab.A laboratory guidewire insertion test was able to be performed, and the insertion was successful, and no restriction was felt.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal tubing and extender tubing was performed, and no leaks were detected.A leak may impact the ability to maintain vacuum.We are able to confirm the reported failure.The kink observed on the catheter tubing may have contributed to the difficult of inserting the iab into the guidewire.However, we are unable to determine when this issue have taken place.The 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.

• Brand Name: LINEAR 7.5FR. 40CC IAB (INDIA)
• 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: 20171450
• Report Number: 2248146-2024-00537
• Device Sequence Number: 15471255
• Product Code: DSP
• UDI-Device Identifier: 10607567109718
• UDI-Public: (01)10607567109718(10)3000371532(17)270321(11)240321
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/12/2025

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: 0684-00-0480-07
• Device Catalogue Number: 0684-00-0480-07
• Device Lot Number: 3000371532
• 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: 08/20/2024
• Supplement Date Received by Manufacturer: 11/12/2024; 09/03/2025
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 11/13/2024; 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2024
• 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: UNKNOWN.
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 69 KG