MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION RADIFOCUS INTRODUCER II KIT; INTRODUCER, CATHETER

Model Number N/A

Device Problem Difficult to Advance (2920)

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

Event Type  malfunction  

Event Description

The user facility reported that the doctor stated 6fr interventional guide catheters are very tight in the 6fr pinnacle sheath, causing some guides to kink outside the sheath when trying to manipulate the catheter.Additional information was received on 15 jun 2022: the physician stated that the procedure went smoothly.

Manufacturer Narrative

Expiration date - unknown due to unknown lot number.Udi - unknown due to unknown lot number.Implanted date: device was not implanted.Explanted date: device was not explanted.Initial reporter occupation - staff interventional cardiologist.Device manufacture date - unknown due to unknown lot number.The actual device was not returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record.

Manufacturer Narrative

This report is being submitted as follow-up no.1 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The complaint cannot be confirmed since the device was not available for evaluation.The exact root cause cannot be determined.The device history record (dhr) could not be reviewed since the lot number was not available.Currently no action is recommended since this risk evaluation is within the predetermined limits in the failure mode & effects analysis (fmea).

• Brand Name: RADIFOCUS INTRODUCER II KIT
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer Contact: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 14945059
• MDR Text Key: 303917922
• Report Number: 1118880-2022-00055
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954234
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: RSS602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1