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

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	10/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the destination device involved was used and medical intervention required.Viabahn stent was needed to fix the dissection.The patient condition was not affected.The patient procedure outcome was not affected.The event occurred intra-operative.Additional information was received on (b)(6) 2022: the procedure performed for the patient was a carotid angio imaging study.The carotid was stented to resolve the issue and continue the procedure.Ultimately the procedure was successful.The patient condition was stable and discharged as normal.The destination device caused the dissection that needed to be stented.A short 6 french 10 cm pinnacle sheath was in the common femoral artery and used through a headhunter catheter with a gwa.035 to take images.The tortures right common carotid was noted, super stiff amplatz was placed through the headhunter, headhunter was removed a 6 french 90cm straight destination sheath was placed in the common carotid, imaging was done through the sheath dissection noted at the time.An 8mm x 5cm gore viabahn stent was placed in the right carotid.
Additional Manufacturer Narrative
Occupation: inventory manager.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.A review of the device history record of the product code/lot number combination was conducted with no findings.The complaint cannot be confirmed for destination insertion difficulties because the sample was not returned for assessment.The exact root cause of the arterial dissection could not be determined.The complaint description states that a stiff wire and headhunter were pushed through tortuous anatomy.Imaging that discovered the dissection did not take place until after the vessel was significantly manipulated with these strong concomitant devices.It is very likely this manipulation caused the dissection.Review of device history record (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 hazard based risk table (hbrt).

• Brand Name: DESTINATION CAROTID 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: gina digioia ; 950 elkton blvd.; elkton, MD 21921 ; 6402040886
• MDR Report Key: 15712898
• Report Number: 1118880-2022-00083
• Device Sequence Number: 12426389
• Product Code: DYB
• UDI-Device Identifier: 00389701006796
• UDI-Public: 00389701006796
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2022

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: 09/01/2024
• Device Model Number: N/A
• Device Catalogue Number: RSC01
• Device Lot Number: 0000167593
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2022
• 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: 6FR 10 CM PINNACLE SHEATH, HEADHUNTER CATHETER; 6FR 90 CM STRAIGHT DESTINATION SHEATH; 8MMX5CM GORE VIABAHN STENT; GWA .035, SUPER STIFF AMPLATZ
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 61 KG