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

Model Number	0684-00-0479-07
Medical Device Problem Codes	Leak/Splash (1354); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after 63 hours of intra-aortic balloon (iab) therapy, blood particles were seen inside the iab.It was also noted that blood had entered the pump.The iab was then removed, though, this issue caused difficulty with removal.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
Event site telephone: (b)(6) event site postal code: 560052 additional email address: (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 after 63 hours of intra-aortic balloon (iab) therapy, blood particles were seen inside the iab.It was also noted that blood had entered the pump.The iab was then removed, though, this issue caused difficulty with removal.There was no patient harm or adverse event reported.This report is for the iab involved in this event.A separate report has been submitted for the cs100 intra-aortic balloon pump (iabp) under mfg report number 2249723-2023-04768.
Additional Manufacturer Narrative
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
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
**udi related data quality updates only** providing updated device identification information in alignment with gudid.Complaint record id # (b)(4).

• Brand Name: LINEAR 7.5FR. 34CC IAB (INDIA)
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 15 law drive; fairfield NJ
• Manufacturer (Section G): DATASCOPE CORP.; 15 law drive; fairfield NJ
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ
• MDR Report Key: 18039768
• Report Number: 2248146-2023-00645
• Device Sequence Number: 15336185
• Product Code: DSP
• UDI-Device Identifier: 10607567109695
• UDI-Public: (01)10607567109695(10)3000296535(17)260208(11)230209
• 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,Followup
• Report Date (Section B): 09/05/2024

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: 02/08/2026
• Device Model Number: 0684-00-0479-07
• Device Catalogue Number: 0684-00-0479-07
• Device Lot Number: 3000296535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2023
• Supplement Date Received by Manufacturer: 11/06/2023; 11/28/2023; 09/05/2024
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 11/21/2023; 11/28/2023; 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2023
• 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: CS100 / (B)(6).; UNKNOWN.
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 50 KG