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

Model Number	0684-00-0479-01
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event site postal code: (b)(6).Event site telephone: (b)(6).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
It was reported that during insertion, the guidewire could not be inserted through the intra-aortic balloon (iab).Upon close inspection, a kink in the balloon is observed.A new iab was inserted to continue therapy.There was no patient harm or adverse event reported.
Event or Problem Description
It was reported that during insertion, the guidewire could not be inserted through the intra-aortic balloon (iab).Upon close inspection, a kink in the balloon is observed.A new iab was inserted to continue therapy.
Additional Manufacturer Narrative
The product was returned with the membrane completely unfolded and no blood observed on the returned device or components.One kink was observed on the catheter tubing approximately 76.2cm from the iab tip.Additionally, two kinks were observed on the inner lumen approximately 19cm and 18.3cm from the iab tip.Maquet guidewire, extender tubing, pressure tubing, dilator, sheath, three-way stopcock and angiographic needle were also returned.- the technician attempted to insert the returned 0.025¿ guide wire through the inner lumen of a reference 7.5fr catheter and was unable to successfully insert the guide wire due to the inner lumen kinks.The evaluation confirms the reported failure modes, the difficult/unable to insert iab through guidewire failure was most likely due to the inner lumen kink observed on the inner lumen.However, we are unable to determine how this failure may have occurred.A lot history record review was completed for the reported product.No nonconformances were found that are related to the event.Complaint id no.(b)(4).

• Brand Name: LINEAR 7.5FR. 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: 20795431
• Report Number: 2248146-2024-0000738
• Device Sequence Number: 7809613
• Product Code: DSP
• UDI-Device Identifier: 10607567106557
• UDI-Public: (01)10607567106557(10)3000374811(17)270329(11)240329
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K041281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 02/11/2025

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: 0684-00-0479-01
• Device Catalogue Number: 0684-00-0479-01
• Device Lot Number: 3000374811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 55 KG