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

Model Number	0684-00-0480-01C
Medical Device Problem Codes	Inflation Problem (1310); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to characterization limit e1: event site address: (b)(6).Event site telephone: (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 by the customer that during the insert of intra-aortic balloon (iab) catheter, found the iab can not fully inflation.There was no patient harm or injury reported.
Additional Manufacturer Narrative
Updated fields: b4, d9 (device available for evaluation and date return to manufacture), g3, g6, h2, h3, h6 (type of investigation, investigation findings, investigation conclusions), h11.The iab was returned with the membrane completely unfolded.No blood was observed on the catheter.A kink was found on the catheter tubing and inner lumen near the y fitting approximately 759 cm from the iab tip.A second kink was found on the catheter tubing near the y fitting approximately 765 cm from the iab tip.An underwater leak test of the balloon catheter y fitting and extracorporeal tubing was performed and no leaks were detected.The iab was placed on the cs300 pump and the iab fully inflated.No alarm sounded from the pump.The evaluation determined kinks in the catheter tubing and inner lumen.It is difficult to determine when or how a kink in the catheter occurs.Although we did not repeat the event in the laboratory setting a kink in the catheter can cause inflation difficulty or an alarm.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 nonconforming 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 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 (CHINA)
• 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: 24367766
• Report Number: 2248146-2026-0000702
• Device Sequence Number: 9471349
• Product Code: DSP
• UDI-Device Identifier: 10607567109343
• UDI-Public: (01)10607567109343(10)3000462250(17)280320(11)250320
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 03/23/2026

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: 0684-00-0480-01C
• Device Catalogue Number: 0684-00-0480-01C
• Device Lot Number: 3000462250
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2025
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 50 KG