MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE, OUS; DEVICE, HEMOSTASIS, VASCULAR

Model Number	C610135
Medical Device Problem Code	Break (1069)
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, implant date - the device was not implanted, explant date - the device was not explanted, health professional - requested, not provided, occupation - requested, not provided.A review of the device history record of the product code/lot# combination was conducted with no findings.One 8f angio-seal evolution device was returned for product evaluation.The sheath and carrier tube assembly were returned along with the guidewire, locator and header bag.Upon visual analysis, the sheath shaft broke below the hub of the sheath.The guidewire was inserted through the locator and the sheath hub.There was yellow discoloration observed on the sheath pieces under the microscope.Only two small pieces of the sheath were returned, and they were brittle upon application of minor force.The device sleeve of the carrier tube assembly was in the forward lock position and color bands are not exposed.The complaint could be confirmed for fractured/broken sheath upon investigation.The sheath was returned broken and not all the pieces were returned.The sheath can become shattered and cracked due exposure to light and similar uv light sources.It was also noted that the device was used a day after the expiration date on the package.The ifu and the labelling on the device warns the user against exposure to sunlight including uv light and usage of device post the expiration date.Capa (b)(4) has been initiated to investigate this issue in the past and a notification was sent to capa owner.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.
Event or Problem Description
The user facility reported that the angio-seal device had disintegrated.

• Brand Name: ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE, OUS
• Common Device Name: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 2101 cottontail ln.; somerset NJ 08873
• Manufacturer (Section G): TERUMO MEDICAL CORPORATION; 265 davidson ave; suite 320; somerset NJ 08873
• Manufacturer Contact: stephanie handy ; 950 elkton blvd; elkton, MD 21921 ; 9499890491
• MDR Report Key: 13419927
• Report Number: 2243441-2021-00069
• Device Sequence Number: 5785728
• Product Code: MGB
• UDI-Device Identifier: 00389701011776
• UDI-Public: 00389701011776
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P930038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/01/2022

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: 10/31/2021
• Device Model Number: C610135
• Device Catalogue Number: C610135
• Device Lot Number: 7749635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown