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

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.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 ik device had a hole on the side tube of the sheath.Once contrast was injected, it shot out of the hole.The sheath was the replaced.The estimated blood loss was less than 250cc's.The patient was in stable condition.The procedure outcome was successful.There was no patient injury, medical/surgical intervention required.Additional information was received on 11september2020: the case was left heart catheterization (lch).
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the additional information to section b5.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.
Event or Problem Description
Additional information was received on 21october2020: the side tube or the sheath was not exposed to any sources of heat at any time during the procedure.The pinhole was not noted when the sheath was prepped.The sheaths were stored in the box they come in.This was the only sheath which had this damage.Additional information was received on 10november2020: it was reported that the doctor uses a power injector 2/3rds of the time during a procedure.There was a good chance it was used.The dilator was not in when contrast media was put in.There were no issues noted on the sheath while it was flushed.The sheath was placed in the patient.The side port did become kinked prior to the groin angiogram.When the groin angiogram was taken, the hole was noticed.Not sure how or when the side port became kinked.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to report that this reported event has been reassessed and was deemed not reportable based of the investigation of the actual sample.

• 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: 10627757
• Report Number: 1118880-2020-00235
• Device Sequence Number: 3205446
• Product Code: DYB
• UDI-Device Identifier: 00389701007472
• UDI-Public: 00389701007472
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,Followup
• Report Date (Section B): 10/05/2020

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: 09/30/2022
• Device Model Number: N/A
• Device Catalogue Number: RSS602
• Device Lot Number: YE15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 10/21/2020; 10/21/2020
• Initial Report FDA Received Date: 10/05/2020
• Supplement Report FDA Received Date: 11/17/2020; 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR