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 Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete event site city: (b)(6) event site postal code event site telephone.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 passed through the intra-aortic balloon (iab).Upon inspection, a depression was found on the iab 10 centimeters from the tip.There was no damage noted to the iab packaging.A new iab was inserted successfully to continue therapy without further issue.There was no patient harm or adverse event reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The product was returned with the membrane partially unfolded and blood on the exterior of the catheter.A kink was observed on the catheter tubing approximately 75.4cm from the iab tip.The inner lumen was observed to be occluded.The occlusion was able to be cleared.The technician attempted to insert the returned 0.025¿ guide wire through the inner lumen and the inner lumen was observed to be occluded.The technician was able to clear the occlusion and the guidewire was then successfully inserted.The inner lumen was observed to be occluded with dried blood, confirming the reported difficulty to insert iab through the guidewire.Additionally, the evaluation confirmed the reported kink.We are unable to determine how this may have occurred.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Reference complaint #(b)(4).
Additional Manufacturer Narrative
Udi related data quality updates only.Providing updated device identification information in alignment with gudid (d1, d2, d3, d4, g4, h4, h5).Complaint record id # (b)(4).

• 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: brian schaeffer ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 18753923
• Report Number: 2248146-2024-00101
• Device Sequence Number: 3740681
• Product Code: DSP
• UDI-Device Identifier: 10607567109343
• UDI-Public: (01)10607567109343(10)3000300846(17)260301(11)230301
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K041281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/14/2024

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: 03/01/2026
• Device Model Number: 0684-00-0480-01C
• Device Catalogue Number: 0684-00-0480-01C
• Device Lot Number: 3000300846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2024
• Supplement Date Received by Manufacturer: 03/18/2024; 10/14/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 03/18/2024; 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 79 KG