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

Model Number	N/A
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pt info: unk.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 catheter could not be passed easily through the sheath once femoral access was obtained.A 6fr guide was used with the ik device.The sheath was removed and another cordis 6fr sheath was used.The case was completed normally.The patient was in stable condition.The procedure was completed normally.There was no patient injury, medical/surgical intervention required.Additional information was received on 27july2021: the procedure was a percutaneous coronary intervention (pci).
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 6fr pinnacle introducer kit was returned for product evaluation.The returned sample included the sample packaging, sheath and dilator.There were blood-like substances found on the returned sample.The sheath was mated to the dilator.The sheath and dilator were subjected to visual analysis.No signs of visual deformation were observed on the sheath and dilator.Functional testing was performed.The dilator was flushed with water and no blockages were observed.The dilator was removed and reinserted through the sheath valve.No abnormal resistance was felt.Measurements were taken of the sheath id.The sheath id was found to be 0.082" (2.082mm) which is within specification of >/= 2.02mm.This measurement is within specification based on the ik input/output (i/o) matrix.The complaint cannot be confirmed since the sheath id is within specification and the not enough information about the concomitant device was provided.The exact root cause cannot be determined.The dhr review determined that 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 failure mode and effects analysis (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: 12324999
• Report Number: 1118880-2021-00187
• Device Sequence Number: 4301879
• Product Code: DYB
• UDI-Device Identifier: 00389701007472
• UDI-Public: 00389701007472
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2021

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: 07/01/2023
• Device Model Number: N/A
• Device Catalogue Number: RSS602
• Device Lot Number: 0000036411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Initial Date Received by Manufacturer: 07/22/2021
• Supplement Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 08/16/2021
• Supplement Report FDA Received Date: 09/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6FR GUIDE; 6FR GUIDE
• Patient Age: 56 YR