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

Model Number	N/A
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the involved destination device dilator did not attach to the introducer and retract when entering the patient.The patient was not injured during the event and medical or surgical intervention was not required.The event occurred intra-operative.
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.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 number combination was conducted with no findings.
Additional Manufacturer Narrative
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 24 oct 2022: there was no reported damage noted prior to using the destination device.To continue the procedure the issue was resolved by using a new device.Patient was in stable condition.Procedure was successful.
Additional Manufacturer Narrative
This report is being submitted as follow-up no.2 to provide the completed investigation results.One 8fr destination sheath with the dilator fully inserted were returned for product evaluation.The sheath and dilator were subject to visual analysis.There was a region measured to be 14.5cm from the sheath tip of cracking of the sheath.The tip of the dilator was also observed to be deformed and folded inward.The complaint cannot be confirmed for dilator assembly difficulty because the dilator would fully mate with the sheath and would not easily back out of the connection.The exact root cause could not be determined.The likely root cause is that the deformation of the sheath and dilator tip caused increased friction of the dilator when passing through the vasculature such that it ceased to advance into the artery and back out of the sheath.The cause of this deformation is unknown.The dilator tip may have met a hard surface.Review of device history record (dhr) showed there were no issues noted during manufacture of the product that could have contributed to this complaint condition.Currently no action is recommended since this risk evaluation is within the predetermined limits in the design failure mode and effects analysis (dfmea).

• Brand Name: DESTINATION PERIPHERAL GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer Contact: gina digioia ; 950 elkton blvd.; elkton, MD 21921 ; 6402040886
• MDR Report Key: 15656543
• Report Number: 1118880-2022-00079
• Device Sequence Number: 20325160
• Product Code: DYB
• UDI-Device Identifier: 00389701009414
• UDI-Public: 00389701009414
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/23/2022

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: 05/01/2024
• Device Model Number: N/A
• Device Catalogue Number: 54-84501
• Device Lot Number: 0000127457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2022
• Supplement Date Received by Manufacturer: 10/24/2022; 11/29/2022
• Initial Report FDA Received Date: 10/23/2022
• Supplement Report FDA Received Date: 11/22/2022; 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female