MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION 8F ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE, US; DEVICE, HEMOSTASIS, VASCULAR

Catalog Number	C610135
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has not been received 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 they were closing a femoral artery arteriotomy site with an 8fr angio-seal evolution.While attempting to deploy the device, the angio-seal sheath fractured into many small pieces.It was reported that the angio-seal sheath was very brittle and essentially disintegrated.They attempted to remove all the fractured pieces of device, however they are uncertain if they were able to extract all the device fragments from the patient.The procedure was completed with manual compression.Additional information was received on october 23, 2018: it was reported that the fractured pieces were removed by hand and it appeared they were able to remove all of it.Imaging showed no apparent sign of the product fragments left in the patient.The hospital did additional imaging and kept the patient overnight to try to make sure there weren't any complications and no visible fragments were present.After taking the precautions the hospital decided it was safe to discharge the patient and did not feel the angio-seal fragments were present.No other equipment was used with the angio-seal device.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.One 8f angio-seal evolution was returned for evaluation.The carrier tube assembly was returned lodged within the original packaging tray.The dilator was returned as well.There were broken pieces of the hemostasis sheath visible on the packaging which enclosed the returned device.The hub of the hemostasis sheath was returned with some part of the attached tube.No damage was observed on the carrier tube assembly.The portions of the hemostasis tube were checked for maneuverability and they shattered upon application of minor force.The sheath tubing cracked in multiple locations distal to the hemostasis hub.The damage was consistent with exposure to ultraviolet light and subsequent material degradation.No other visual anomalies were noted.The device should be kept away from sunlight and uv light.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation results, it is likely that the device was exposed to ultraviolet light which led to reported event.However, the exact cause of the reported event cannot be definitively determined.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to provide the attach medwatch.Attachment: [medwatch report mw5080945.Pdf].

• Brand Name: 8F ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE, US
• Common Device Name: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 2101 cottontail ln.; somerset NJ 08873
• MDR Report Key: 8024445
• Report Number: 2243441-2018-00109
• Device Sequence Number: 1353101
• Product Code: MGB
• UDI-Device Identifier: 00389701011776
• UDI-Public: 00389701011776
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P930038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2018

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: 10/31/2018
• Device Catalogue Number: C610135
• Device Lot Number: 6225209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 11/02/2018; 12/05/2018
• Initial Report FDA Received Date: 10/31/2018
• Supplement Report FDA Received Date: 11/05/2018; 12/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 72