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	06/14/2021
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.For this reason, investigation conclusions code has been referenced.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 introducer was pinched in the middle making it impossible to insert other devices.The device was unusable and there was no patient involved.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to provide the device return date in section d9, and to update section h3.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.
Event or Problem Description
Additional information was received on 19jul2021.The device was not used.Another device was used to ensure the operation went smoothly.No clinical consequences were noted.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide additional information in section b5 and 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 mechanical damage since the sample was not returned for evaluation.Based on the information given, the exact root cause of the event cannot be determined.There is no indication that any manufacturing, design or quality system issues may have led to this event.Currently, no action is recommended since this risk evaluation is within the predetermined limits in the fmea.
Additional Manufacturer Narrative
This report is being submitted as follow up no.3 to update section h3, and to provide the completed investigation results.One 6fr 90cm destination mp was returned for product evaluation.The returned product included the packaging, dilator, and sheath.The dilator was inserted into the sheath.The sheath and dilator were subjected to visual analysis.The length of dilator shaft sticking out of the sheath valve was found to be 53.6cm.A portion of the sheath was found to be flattened.The flattened portion was 42.3cm to 44.6cm from the sheath hub.Functional testing was performed.The dilator was attempted to be fully mated with the sheath.The dilator could not advance past the flattened portion.Dimensional testing was performed.Measurements were taken of the sheath id and od.The id was found to be 0.087" which was within specification of 0.087" ± 0.002".The od was found to be 0.112" which was below the maximum od specification of 0.114".Both measurements were within the manufacturer's specifications.The complaint can be confirmed for mechanical damage.The exact root cause of the event cannot be determined.The likely root cause is the user flattened the sheath while handling it.The dhr review determined that the device was in a conforming state when released from terumo control.There is no indication that any manufacturing issues may have led to this event.Currently, no action is recommended since this risk evaluation is within the predetermined limits in the 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: 12168275
• Report Number: 1118880-2021-00165
• Device Sequence Number: 3820107
• Product Code: DYB
• UDI-Device Identifier: 00389701007861
• UDI-Public: 00389701007861
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/14/2021

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: 11/30/2022
• Device Model Number: N/A
• Device Catalogue Number: RSC07
• Device Lot Number: YG10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Initial Date Received by Manufacturer: 06/18/2021
• Supplement Date Received by Manufacturer: 07/19/2021; 08/30/2021; 09/23/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 08/13/2021; 09/21/2021; 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1