MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD MEGA 7.5FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0295-05

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/12/2023

Event Type  malfunction  

Manufacturer Narrative

Complete event site name: (b)(6)hospital.Event site postal code: (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 Description

It was reported that prior to inserting the guidewire, it was noted that the angiographic needle tail was cracked.It was noted that the operator connected a syringe to the puncture needle tail when inserting the needle.Another insertion kit was opened and used to continue.There was no patient harm or adverse event reported.

Manufacturer Narrative

The angiographic needle was returned without blood was visible on the component.The extender tube, step dilator, 2-pressure tubing, stop cock, and guide wire were also returned.A crack was observed on the hub of the angiographic needle.We are unable to determine when this may have occurred.The evaluation confirms the reported problem.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 Description

N/a.

• Brand Name: MEGA 7.5FR. 40CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ
• MDR Report Key: 17333298
• MDR Text Key: 319761997
• Report Number: 2248146-2023-00449
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567109039
• UDI-Public: 10607567109039
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K120868
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0684-00-0295-05
• Device Catalogue Number: 0684-00-0293
• Device Lot Number: 3000244401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 54 KG