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

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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.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 destination hub detached, the hub was dislodged from the catheter.There was no patient harm.Additional information was received on 25feb2020.The procedure being performed was a carotid artery stenting (cas).The procedure was completed successfully with a new destination sheath.No blood loss was reported.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide an update to state that the reported event has been deemed not fda reportable based off the photos provided by the user facility.

• 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: 9764167
• Report Number: 1118880-2020-00055
• Device Sequence Number: 714027
• Product Code: DYB
• UDI-Device Identifier: 00389701006796
• UDI-Public: 00389701006796
• Combination Product (Y/N): N
• Initial Reporter Country: MK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2020

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: 08/31/2021
• Device Model Number: N/A
• Device Catalogue Number: RSC01
• Device Lot Number: XD27
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 80