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 Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier - requested, not provided.Age & date of birth - requested, not provided.Patient sex - requested, not provided.Weight - requested, not provided.Ethnicity - requested, not provided.Race - requested, not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.Health professional: unknown.Occupation - director of cardiovascular.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 when they opened a 6 fr destination sheath the stopcock was not secure in the packaging and fell on the floor.A new destination sheath had to be opened.There was no patient injury, medical/surgical intervention required.Additional information was received on 23april2021: the patient was in stable condition; the product packaging issue did not affect the procedure.The procedure was completed successfully using a second destination.The procedure performed was a heart catheterization.This occurred before the patient was loaded in the cath lab room.The staff was getting the room ready and opened the destination to have it ready to go.This is when the stop clock fell out of the packaging because it was not secure.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The complaint cannot be confirmed for valve assembly difficulty.The cause of the event cannot be determined at this time as it is likely that the valve assembly could have unscrewed from the sheath hub from the sheath hub at an unknown time pre usage at the clinical facility.Currently, no action is recommended since this risk evaluation is within the predetermined limits in the failure mode and effects analysis (fmea).

• Brand Name: DESTINATION CAROTID GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 11778018
• Report Number: 1118880-2021-00094
• Device Sequence Number: 3138760
• Product Code: DYB
• UDI-Device Identifier: 00389701007847
• UDI-Public: 00389701007847
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2021

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: 07/01/2023
• Device Model Number: N/A
• Device Catalogue Number: RSC05
• Device Lot Number: 0000034540
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1