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

Model Number	N/A
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	12/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: radiological technologist.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.
Event or Problem Description
The user facility reported that during a right leg intervention via left common femoral approach, the destination sheath was stuck and when the sheath was pulled it separated.A cut down was performed, and the sheath was removed.The patient was closed; however, then returned for a left leg angiogram via the right common femoral artery because the below knee arteries had clotted off.The blood loss was greater than 250cc's.The patient was in stable condition.Additional information received 14-december-2021: the inner coil was exposed.The user facility stated they suspect that the access may have been through a previous self-expanding stent.
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 7fr destination was returned for product evaluation.The returned sample included the sheath.An 8fr non-terumo sheath was also returned.The returned sample was subjected to visual analysis.The sheath was in two pieces.A piece not coil was also returned not inside any sheath.The first piece was found to be 39.7cm long.There were signs of stretching and flattening that began at 39.0cm from the sheath hub.The second piece was 7.5cm long.A slit was found on the shorter piece that run along most of its length.No coil was found present in the shorter sheath.The complaint can be confirmed for mechanical separation.The exact root cause cannot be determined.The likely root cause is that the destination sheath got caught on the stent.Review of dhr showed there were no issues noted during manufacture of the product that could have contributed to this complaint condition.Currently no action is recommended since this risk evaluation is within the predetermined limits in the fmea.

• 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: 13180102
• Report Number: 1118880-2021-00221
• Device Sequence Number: 5710461
• Product Code: DYB
• UDI-Device Identifier: 00389701006192
• UDI-Public: 00389701006192
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 01/06/2022

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: 01/01/2024
• Device Model Number: N/A
• Device Catalogue Number: RSR04
• Device Lot Number: 0000051357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2021
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2021
• 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: JET STREAM ATHERECTOMY BSCI
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White