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 Codes	Blood Loss (2597); No Code Available (3191)
Date of Event	09/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.(b)(4).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 the patient had an a-fib ablation, with left femoral vein access using a radifocus introducer ii kit.After the procedure and during sheath removal, the sheath separated from the hub.It was not a clean break.The doctor had to remove the remaining body of the sheath by doing an incision and removing with a kelly clamp.The patient was stable at the end of the sheath removal.The procedure outcome was successful.Additional information was received on 9/21/18: the reported blood loss was estimated to be 10 cc.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date, to update and to provide the completed investigation results.One 6 fr sheath was returned to for product evaluation.The sheath was returned in two separate pieces.Visual inspection revealed that the sheath was not separated in a clean fashion and the edges were jagged.Microscopy inspection revealed no other anomalies were noted with the sheath.Dimensional analysis of the sheath revealed that the distal tip to edge of the first separated section measured 0.2595".The base of the hub to the distal edge of the second separated section measured 3.7585".A kink in the sheath was also present and measured 2.6065" from the distal tip of the sheath.No other anomalies were noted.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation results, it is likely that the application of off axis forces could have contributed to the reported event.However, the exact cause of the reported event cannot be definitively determined.

• 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: 7929602
• Report Number: 1118880-2018-00139
• Device Sequence Number: 13937109
• Product Code: DYB
• UDI-Device Identifier: 00389701007250
• UDI-Public: 00389701007250
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 10/03/2018

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: No Information
• Device Expiration Date: 09/30/2020
• Device Model Number: N/A
• Device Catalogue Number: RSS601
• Device Lot Number: WF02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Initial Date Received by Manufacturer: 09/19/2018
• Supplement Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 11/15/2018
• 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: A-FIB ABLATION EQUIPMENT.
• Outcome Attributed to Adverse Event: Required Intervention