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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	07/31/2020
Type of Reportable Event	Serious Injury
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.[fda mw5095882.Pdf].
Event or Problem Description
The user facility reported that the tip of the sheath broke off when removing the sheath at the end of the case.The common femoral artery was fairly calcified.The doctor had to snare the broken piece out and everything was ok.The patient was in stable condition.The procedure outcome was successful.The blood loss was less than 250 cc's.There was no patient injury, medical/surgical intervention required.Additional information was received on 19aug2020: terumo medical received an fda medwatch report # mw5095582.The event description states: "during intra-op angiogram, inducer tip came off when surgeon was placing the guidewire.Surgeon was able to retrieve the tip from the patient.".
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 used 6 fr ik pinnacle sheath was received for product evaluation.The dilator and sheath were received unmated.No other accessory components were returned.The sample was decontaminated per terumo medical corporation's procedures and policies.After decontamination, the sheath was subjected to visual analysis.The sheath was received in two segments.The first segment of the sheath measured 8.3 cm from the hub and the second segment measured 1.7 cm.Microscopic analysis of both the broken segments of the sheath showed a ductile deformation.A slight kink was observed at 4.7 cm on the surface of the sheath from the hub.No other anomalies were noted with the returned components.The sheath can be confirmed for sheath tip separation.A nonconformance and health hazard evaluation was issued to further investigate the issue.Per the nonconformance investigative report, based on the defect rate for product in the field and the results of the reinspection, it is concluded that the material currently in the field is safe for use.

• Brand Name: RADIFOCUS INTRODUCER II KIT
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton, md
• MDR Report Key: 10449228
• Report Number: 1118880-2020-00203
• Device Sequence Number: 11773268
• Product Code: DYB
• UDI-Device Identifier: 00389701007472
• UDI-Public: 00389701007472
• Combination Product (Y/N): N
• 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): 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: N/A
• Device Catalogue Number: RSS602
• Device Lot Number: YD18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Initial Date Received by Manufacturer: 07/31/2020
• Supplement Date Received by Manufacturer: 01/05/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 01/07/2021
• 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: 8FR SHEATH AND SNARE; 8FR SHEATH AND SNARE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Weight: 110