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

Model Number N/A

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/07/2021

Event Type  malfunction  

Manufacturer Narrative

Implanted date - device not implanted.Explanted date - device not explanted.The actual device has been returned for evaluation.The investigation is currently 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 the nurse found the angio-seal packaging was not sealed completely which then made them feel that the product inside was not sterile.He switched to another new angio-seal.There was no patient injury/medical or surgical intervention required.The patient was in stable condition.There were no other devices or equipment used with the reported product.Additional information was received on 11jun2021.Before opening the package, the nurse found that the package was not fully sealed.After the percutaneous coronary intervention (pci) procedure, the doctor confirmed the wound site with x-ray and asked the nurse to prepare the closure device.The nurse found that the packing was not fully sealed.Hemostasis was successful with the second device opened for use in the procedure.

Manufacturer Narrative

This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.One unused 8fr angio-seal vip device was received for product evaluation at terumo medical corporation.Upon visual analysis, it was noted that the seal of the device was not complete.Seal was observed under the microscope and signs of peel off mark was observed.To further investigate the issue, a complaint has been initiated with the manufacturing facility.Based on the finding of the evaluation, the complaint could be confirmed for damaged seal.Based on the investigation and the peel off mark present on the seal, the root cause of this event cannot be attributed to manufacturing but to handling post manufacturing.No actions are applicable since the root cause was not attributed to the manufacturing process.Based on the finding of the evaluation, the complaint could be confirmed for missing control temperature label.Based on the investigation, the principle root cause of this event was attributed to inspection method during manufacturing.Currently, no action is recommended since this risk evaluation is within the predetermined limits in the fmea.

• Brand Name: 8F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, OUS
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 265 davidson ave; suite 320; somerset NJ 08873
• Manufacturer (Section G): TERUMO PUERTO RICO LLC; innovacion street lot 21; caguas west industrial park; caguas, 00725
• Manufacturer Contact: mary o'neill ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 12119796
• MDR Text Key: 260592777
• Report Number: 3013394970-2021-00387
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: P930038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 610133
• Device Lot Number: 0000038908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian