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

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.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 it was noticed that the involved 6fr destination sheath was kinked after opening the box.The box was not damaged; however, the sheath was kinked.The product was not used.A cook 6fr sheath was used instead.The patient was in good condition and the outcome of the procedure was good.There was no patient injury, medical/surgical intervention required.Additional information was received on 24mar2020.The type of procedure being performed was an abdominal and lower extremity run offs.
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 90 cm 6fr destination sheath and dilator were received for evaluation.Visual inspection revealed that both components were returned folded in a u-shape.The sheath was viewed under microscope and it was noted that the sheath was flattened 45 cm from the hub.No other anomalies were noted on the dilator.The packaging for the device was not returned for evaluation.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It is likely that mishandling of the packaging tray may have caused the damage noted on the sheath.However, without the return of the packaging tray, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: DESTINATION CAROTID GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton, md
• MDR Report Key: 9947596
• Report Number: 1118880-2020-00088
• Device Sequence Number: 3271598
• Product Code: DYB
• UDI-Device Identifier: 00389701006796
• UDI-Public: 00389701006796
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2020

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: 06/30/2021
• Device Model Number: N/A
• Device Catalogue Number: RSC01
• Device Lot Number: XA16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Initial Date Received by Manufacturer: 03/18/2020
• Supplement Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 04/10/2020
• Supplement Report FDA Received Date: 05/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention