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

Model Number	N/A
Medical Device Problem Codes	Difficult to Insert (1316); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.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.
Event or Problem Description
The user facility reported that the destination device involved dilator would not advance into the sheath fully.It would get caught roughly halfway through the sheath.Another sheath was reported, and the dilator would not advance into the sheath fully.It would get caught roughly halfway through the sheath.Then a third sheath was opened, and the same thing happened.The doctor cut the sheath opened to see what was going on and stated that the coil reinforcing had some sort of kink/damage to it.Both sheaths that were opened with the same and were not used.The third sheath was opened and there was no issue with it, and the case was completed successfully.Blood loss was less than 250cc's.The patient recovered.The event occurred intra-operative.The patient was not injured, and medical or surgical intervention was not required.Additional information was received on 18 jul 2022: the procedure performed was a peripheral artery disease (paod) angiogram and treatment of the left leg.The patient condition was stable at the end of the procedure, as they opened a third device, and it was functional.
Additional Manufacturer Narrative
This report is being submitted as follow-up no.2 to update section h3, and to provide the completed investigation results.One 6fr destination sheath and dilator were returned for assessment.There were no visual abnormalities on the dilator.The sheath was separated 18.5cm from the hub.The sheath tip inner diameter (id) was measured to be 0.086in, and the specification is >=0.085in.The dilator outer diameter (od) was measured to be 0.082in, and the specification is <=0.085in.All measurements were within manufacturing specifications.The complaint could not be confirmed for sheath and dilator mobility as the sheath and dilator were within specifications.The complaint description mentions that the sheath was kinked, but the doctor cut the sheath open at the alleged kink point and thus no conclusions can be made about whether the damage to sheath was caused by the cutting process or was there prior.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 design failure mode and effects analysis (dfmea).
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d9 and to update section h3.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.

• Brand Name: DESTINATION PERIPHERAL 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: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 15168937
• Report Number: 1118880-2022-00060
• Device Sequence Number: 5121032
• Product Code: DYB
• UDI-Device Identifier: 00389701007786
• UDI-Public: 00389701007786
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/04/2022

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: Health Professional
• Device Expiration Date: 10/01/2022
• Device Model Number: N/A
• Device Catalogue Number: RSP01
• Device Lot Number: 0000176713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2022
• Supplement Date Received by Manufacturer: 08/10/2022; 09/09/2022
• Initial Report FDA Received Date: 08/04/2022
• Supplement Report FDA Received Date: 09/08/2022; 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2022
• 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: GLIDEWIRE ADVANTAGE .035" 260 CM
• Patient Sex: Unknown