MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION 6F ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE, US; DEVICE, HEMOSTASIS, VASCULAR

Catalog Number C610134

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2020

Event Type  Injury  

Manufacturer Narrative

Patient identifier - requested, not provided.Weight - requested, not provided.Ethnicity - requested, not provided.Race - requested, not provided.Lot number - requested, not provided.Expiration date - unknown due to unknown lot number.Udi - unknown due to unknown lot number.Explanted date: device was not explanted.Device manufacture date - unknown due to unknown lot number.The actual device was not 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.

Event Description

The user facility reported that they experienced more than normal track oozing after deployment.The physician stated that his access was at less than a 45-degree angle.After deployment he also stated that there was disease in the artery and that it puffed up.They held pressure longer than their standard time and ordered the patient remain in bed for an additional hour before discharge.There were no vascular complications.The patient was discharged with no known issues.There was no patient injury/medical or surgical intervention required.The procedure was completed by holding pressure longer and having the patient lay flat longer by an hour.Additional information was received on 17jun2020.The procedure performed was a bilateral lower extremity angiogram and they ballooned the superficial femoral artery (sfa) on the left side.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.With no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: 6F ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE, US
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 265 davidson ave; suite 320; somerset, nj
• MDR Report Key: 10216173
• MDR Text Key: 197144049
• Report Number: 3013394970-2020-00340
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• PMA/PMN Number: P930038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C610134
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR