MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION DESTINATION RENAL GUIDING SHEATH; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	09/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: md, vascular surgery.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 that the doctor had indicated that during the procedure he noticed a hematoma forming on the groin after they had swapped out the pinnacle sheath for a 6fr destination.The registered radiologic technologist rt(r) in the room, was alerted and held pressure on the hematoma during procedure.Upon removal of the sheath, the doctor stated he noticed something different on the distal end of sheath that felt burr like and was visible on distal end of sheath.The staff continued to hold pressure to resolve the hematoma.The patient was good and in stable condition.The procedure was completed successfully.Additional information was received on 06oct2021.The case was a peripheral intervention.
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 6fr destination sheath with its dilator fully inserted and mated were received for product evaluation.The sheath and dilator were subjected to visual analysis and deformation at the tip of the sheath was observed.There was a depression on the side of the tip, and just adjacent to it an elevated bump.The complaint is confirmed for mechanical damage of the sheath tip.The exact root cause cannot be determined.Historically, deformations like the one seen in this complaint occur during sheath insertion.Review of dhr showed there were no issues noted during the manufacture of the product that could have contributed to this complaint condition.No ncs or capas were opened for this issue within the last 12 months.Currently, no action is recommended since this risk evaluation is within the predetermined limits in the hbrt.

• Brand Name: DESTINATION RENAL GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer Contact: mary o'neill ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 12686897
• Report Number: 1118880-2021-00209
• Device Sequence Number: 19759396
• Product Code: DYB
• UDI-Device Identifier: 00389701006185
• UDI-Public: 00389701006185
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K172995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2021

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: 04/01/2023
• Device Model Number: N/A
• Device Catalogue Number: RSR03
• Device Lot Number: 0000015879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2021
• Supplement Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 10/24/2021
• Supplement Report FDA Received Date: 12/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PINNACLE SHEATH; STARTER WIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown