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 Codes	Blood Loss (2597); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device has not been returned to the manufacturing facility for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.For this reason, evaluation code has been referenced in the conclusions.A review of the device history record of the product code/lot# combination was conducted with no relevant findings.A search of the complaint file did not find any other report with the involved product code/lot# combination all available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.Patient and device codes are unable to be selected at this time.Esubmitter support has been notified.
Event or Problem Description
The user facility reported that the sheath valve completely detached from hub during procedure.Additional information was received on 8/24/2017: it was reported that the blood loss was 5cc.It was reported that there was no patient injury or medical intervention required.It was reported that there were no complications with the patient.It was reported that the procedure was successful and that the patient was staying overnight.The only other device used with the reported product was the wire that came with the sheath.
Additional Manufacturer Narrative
One used 9fr ik device was received for product analysis.The returned product was decontaminated.After decontamination, the returned device was subjected to visual analysis.Returned with the sheath was the dilator.There was no valve present in the hub of the sheath.There was evidence in the hub indicating that a valve had once been placed.The returned dilator was examined under microscopy.The tip of the dilator had been deformed occluding the hole of the dilator as though the dilator had encountered a hard surface.The complaint could be confirmed for valve damage as the valve likely became displaced when the dilator was inserted into the sheath.The damage at the dilator tip supports that the dilator was likely inserted off center into the valve, which would have led to the dislodgement.There is no evidence that this event was related to a device defect or malfunction.The exact cause of the reported event cannot be definitively determined based on the available information.

• 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: 6875926
• Report Number: 1118880-2017-00076
• Device Sequence Number: 13594772
• Product Code: DYB
• UDI-Device Identifier: 00389701007281
• UDI-Public: 00389701007281
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2017

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: 08/31/2019
• Device Model Number: N/A
• Device Catalogue Number: RSS901
• Device Lot Number: VD15
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/24/2017
• Supplement Date Received by Manufacturer: 09/26/2017
• Initial Report FDA Received Date: 09/19/2017
• Supplement Report FDA Received Date: 10/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 88