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

Model Number	N/A
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Date of Event	07/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not implanted.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 when inserting the ik wire into the sheath, the valve collapsed.The sheath was removed over the wire and an impella was inserted.The blood loss was greater than 250cc's.The procedure outcome was successful, and the patient was in stable condition.Additional information was received on july 23, 2018.The procedure was a percutaneous coronary intervention.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation.The statement that was initially reported: (b)(4).One 11 fr ik sheath was received for product evaluation.No other components were received with the sheath.The sheath was subjected to visual analysis, and the valve could be seen partially dislodged into the hub of the sheath.The valve was then removed from the sheath and examined.There was an off-center discoloration present on both the topside and bottom side of the valve.There were no other anomalies noted with the valve.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: 7747271
• Report Number: 1118880-2018-00073
• Device Sequence Number: 1560522
• Product Code: DYB
• UDI-Device Identifier: 00389701007304
• UDI-Public: 00389701007304
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2018

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: No Information
• Device Expiration Date: 08/31/2020
• Device Model Number: N/A
• Device Catalogue Number: RSS101
• Device Lot Number: WD07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 08/03/2018
• Supplement Report FDA Received Date: 08/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1