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	No Consequences Or Impact To Patient (2199)
Date of Event	07/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device has not 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 while performing a left heart catheterization and while placing the pinnacle sheath on the.035 guidewire the doctor noticed that the tip of the dilator broke off and was separate from the sheath.The doctor instantly removed the from the guidewire and got another sheath and placed the new pinnacle device in the patient's vessel.The patient did fine and was later discharged home with no adverse events.The sheath was a 5fr x25cm.The procedure was a success and the patient was reported to be in stable condition.Additional information was received information received 06/august/2019: it was reported that pieces of the device was left in the patient.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in the d10 section and to update the h3 section.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to update the section and to provide the completed investigation results.One 5fr introducer kit dilator and sheath were received for product evaluation.Visual inspection revealed that the dilator was examined and damage was observed at the distal tip of the dilator.Microscopy confirmed that the dilator tip was damaged and a small fragment of the tip broke off.The customer sent a picture of the device with the fragment but because the fragment was not returned with the device, the fragment cannot be analyzed for evaluation.The crosscut valve was dissected from the sheath and inspected under a microscope.Damage was observed on the rim of the crosscut valve; the rim was punctured.The sheath inner lumen of the hub was inspected and did not display any obstructions or anomalies.The device history record was reviewed for testing on extrusion for dilator product lot.The ovality, molding inspection and concentricity were within manufacturing specifications.All operations and assembly were done within terumo medical specifications and procedures.Based on the provided information and investigation results there is no evidence that this event was related to a device defect or malfunction.However, the exact cause of the reported event cannot be definitely 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: 8878991
• Report Number: 1118880-2019-00217
• Device Sequence Number: 2048034
• Product Code: DYB
• UDI-Device Identifier: 00389701009322
• UDI-Public: 00389701009322
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K954234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/09/2019

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: 08/31/2021
• Device Model Number: N/A
• Device Catalogue Number: RSB503
• Device Lot Number: XD1313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Initial Date Received by Manufacturer: 07/19/2019
• Supplement Date Received by Manufacturer: 08/13/2019; 10/03/2019
• Initial Report FDA Received Date: 08/09/2019
• Supplement Report FDA Received Date: 09/12/2019; 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR