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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event - (b)(6) 2019.Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device was not 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.[uf medwatch (b)(4)].
Event or Problem Description
Terumo medical received a user facility medwatch report # (b)(4).The event description states: the patient was having a heart catheterization and the terumo sheath broke in half during the case.The patient had to be taken to surgery to retrieve the broken part.Additional information was received on 04nov2019.Blood loss was minuscule.The patient condition is unknown.
Event or Problem Description
A maude database search conducted on (b)(6) 2019 found maude report number (b)(4).The event description states: "the patient was having a heart cath and the terumo sheath broke in half during the case.The patient had to be taken to surgery to retrieve the broken part.".
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide additional information in section b5 and to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.With no return of the actual device, 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: 9364852
• Report Number: 1118880-2019-00330
• Device Sequence Number: 19390863
• Product Code: DYB
• UDI-Device Identifier: 00389701007496
• UDI-Public: 00389701007496
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Report Date (Section B): 11/22/2019

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: 11/30/2021
• Device Model Number: N/A
• Device Catalogue Number: RSS802
• Device Lot Number: XG19
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/01/2019
• Supplement Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR