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

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier - requested, not provided.Age & date of birth - requested, not provided.Patient sex - requested, not provided.Weight - requested, not provided.Ethnicity - requested, not provided.Race - requested, not provided.(b)(4).The actual device has been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record of the product code/lot# combination was conducted with no findings.
Event or Problem Description
The user facility reported that the introducer kit (ik) sheath would not respond to a pressure drip during arterial case.They tried to re-prime the sheath and it came apart.A different sheath was pulled, and they were able to successfully exchange the sheath and complete the case with the new sheath.There was no patient injury/medical or surgical intervention required.The patient was stable, and the procedure outcome was successful.Additional information was received on (b)(6) 2020.The device was in the patient, however the valve was the portion that broke, so that piece was always outside the body.
Additional Manufacturer Narrative
This report is being submitted as follow up, no.1 to update section h3, and to provide the completed investigation results.One 5fr introducer sheath was returned for product evaluation.The plug lock was dislodged from the three-way stopcock body.Visual inspection revealed, that the locking pin was dislodged from the three-way stopcock.The plug lock was viewed under microscope.And damage was seen at the gate.The gate was bent outward.The complaint can be confirmed, for three-way stopcock mechanical separation.Based on the investigation, it is likely the three-way stopcock was turned past 180 degrees causing the locking pin to dislodge, moving the plug lock.The device was in a conforming state when released from terumo control.There is no indication, that any manufacturing issues may have led to this event.Currently no action is recommended, since this risk evaluation is within the predetermined limits in the fmea.

• Brand Name: RADIFOCUS INTRODUCER II KIT
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 11159987
• Report Number: 1118880-2020-00359
• Device Sequence Number: 13677252
• Product Code: DYB
• UDI-Device Identifier: 00389701009315
• UDI-Public: 00389701009315
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K954234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2021

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: 11/30/2022
• Device Model Number: N/A
• Device Catalogue Number: RSB502
• Device Lot Number: YG0313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1