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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation- requested, not provided.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.This report is for the second device reported, for the first device reported that was found during the same event see mdr 1118880-2021-00106.
Event or Problem Description
The user facility reported that they had opened a new destination and noted as it was being removed from the packet that there was a crushed/pinched section on the middle of the sheath.A second destination was opened with the same issue.A third device was opened without issue.There was no patient contact or use.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.One used 8fr 90 cm destination sheath and dilator was returned for product evaluation.The dilator was fully mated to the sheath when received.The sheath was subjected to visual analysis and damage was noted on the sheath tip but not the sheath shaft.No other visual anomalies were observed on the dilator.The outer diameter of the sheath was measured to be 0.136 in which is within manufacturer's specifications.The inner diameter of the sheath tip is 0.115" which was also within the manufacturer's specifications.Blood like stains were noted on the valve assembly.The complaint can be confirmed for sheath tip mechanical damage.Based on the damage observed, the cause of the event cannot be determined, however, it is likely that the tip of the sheath may have come in contact with difficulties at the point of insertion that propagated various forces that deformed the tip of the sheath.Currently, no action is recommended since this risk evaluation is within the predetermined limits in the fmea.
Event or Problem Description
Additional information was received on 06jun2021.The sheath buckled as opposed to pinched.The condition of the vasculature of the patient was stable.The was an out of the box failure with no patient contact.

• 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: 11850053
• Report Number: 1118880-2021-00107
• Device Sequence Number: 17121286
• Product Code: DYB
• UDI-Device Identifier: 00389701009452
• UDI-Public: 00389701009452
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2021

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: 06/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 54-89001
• Device Lot Number: YA15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 06/06/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1