MAUDE Adverse Event Report: DATASCOPE CORP. AMATO PLUS-R 30CC IAB WITH ACCESSORIES AND RETRACTION KIT (APA); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0559-02
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was strong resistance on the distal side of the sheath when inserting the intra-aortic balloon (iab).The iab could not be inserted through the sheath.It was noted that another manufacturer's sheath was being used.Another manufacturer's iab was then inserted through the sheath without issue.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
Occupation: cardiologist.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).
Additional Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood on the exterior of the catheter.The sheath, introducer dilator, and stepped dilator were returned separate from the catheter.A kink was observed on the catheter tubing approximately 71.4cm from the iab tip.The 0.025¿ guidewire was returned inside the inner lumen of the catheter.A 0.035¿ guidewire, angiographic needle, and extender tubing were also returned.A laboratory insertion test was unable to be performed due to the membrane being unfurled.The sheath was measured and found to be within specification.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal, and extender tubing was performed and no leaks were detected.A leak may impact the ability to maintain vacuum.The reported difficulty to insert the iab through the sheath could not be confirmed by the evaluation.We are unable to confirm the reported difficulty during insertion because of the returned condition of the catheter and we are unable to mimic the clinical setting.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).
Event or Problem Description
N/a.
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).
Event or Problem Description
N/a.

• Brand Name: AMATO PLUS-R 30CC IAB WITH ACCESSORIES AND RETRACTION KIT (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: jingal amin ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 18615148
• Report Number: 2248146-2024-00060
• Device Sequence Number: 20727044
• Product Code: DSP
• UDI-Device Identifier: 10607567107592
• UDI-Public: (01)10607567107592(17)251120(10)3000281458(11)221121
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120868
• 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): 11/01/2024

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: 11/20/2025
• Device Model Number: 0684-00-0559-02
• Device Catalogue Number: 0684-00-0559-02
• Device Lot Number: 3000281458
• 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: 01/12/2024
• Supplement Date Received by Manufacturer: 03/12/2024; 11/01/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 03/12/2024; 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2022
• 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: TERUMO 8FR. 24CM SHEATHSENKOSHA 7FR. IAB.
• Patient Sex: Unknown