MAUDE Adverse Event Report: DATASCOPE CORP. GUIDE WIRE 3MM J TIP 0.025" X 145 CM PTFE COATED (TYPE L) FIXED CORE; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0254-09
Medical Device Problem Code	Incomplete or Missing Packaging (2312)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon opening the intra-aortic balloon (iab) guidewire shipment on 26january2024, it was noted that there were no guidewires inside.Instead, there was only a black shelf within the package.There was no patient involvement and no adverse event reported.
Additional Manufacturer Narrative
Complete reporter name: (b)(6) additional reporter: (b)(6) event site postal code: (b)(6) there will be no device return.If new information becomes available, a supplemental report will be submitted.Complaint record id (b)(6).
Additional Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation.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: brand name, unique identifier (udi) #, version or model #.Reference complaint #(b)(4).
Event or Problem Description
N/a.

• Brand Name: GUIDE WIRE 3MM J TIP 0.025" X 145 CM PTFE COATED (TYPE L) FIXED CORE
• 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: 18696211
• Report Number: 2248146-2024-00090
• Device Sequence Number: 8357970
• Product Code: DSP
• UDI-Device Identifier: 10607567105925
• UDI-Public: (01)10607567105925(10)8230976
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K943896
• 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,Followup
• Report Date (Section B): 10/10/2024

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 Model Number: 0684-00-0254-09
• Device Catalogue Number: 0684-00-0254-09
• Device Lot Number: 8230976
• 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: 01/26/2024
• Supplement Date Received by Manufacturer: 04/02/2024; 10/10/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 04/02/2024; 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: N/A.
• Patient Sex: Unknown