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

Model Number N/A

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/06/2020

Event Type  malfunction  

Manufacturer Narrative

Patient identifier - requested, not provided.Weight - requested, not provided.Ethnicity - requested, not provided.Race - requested, not provided.Explanted date: device was not explanted.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.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 angio-seal sheath broke into two when the doctor performed the pull back.A small amount of collagen was sighted at the skin surface, however the doctor managed to push the collagen beneath the skin, and then continued the pull back, holding onto the device sleeve which was still intact to the suture.Hemostasis was achieved, and the patient was ok.There was no patient injury/medical or surgical intervention required.There were no other devices or equipment used with the reported product.Additional information was received on 09jun2020.The procedure performed was a percutaneous coronary intervention (pci).A 6fr procedural sheath was used.A pre-deployment angiogram was performed.The patient was in stable condition.Hemostasis was achieved by the doctor pushing the collagen that was seen at the surface beneath the skin, while he continued pullback while holding on the suture.

Manufacturer Narrative

This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.One used 6fr angioseal vip device was returned for product evaluation.The carrier tube assembly, arteriotomy locator and the broken pieces of the hemostasis sheath were returned for analysis.Visual inspection revealed that the locator was found to be bent in a curved shape and kinked at the blood inlet holes of arteriotomy locator.On the carrier tube assembly, it was noted that the deployment sleeve was in the full rear lock position with the color bands fully exposed.Multiple kinks were observed on the carrier tube assembly as well.The broken pieces of the hemostasis sheath were examined under the microscope and there was some evidence of burrs observed around the breakage surface that could be indicative of sheath being cut manually with a sharp-edged blade.The pieces of the sheath were checked for maneuverability using digital pressure.The sheath tubing held its material integrity and kinked upon the application of high pressure however it did not fracture.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.Based on the investigation results it is likely that the sheath may have been cut with a sharp-edged blade.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: 6F 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
• MDR Report Key: 10216176
• MDR Text Key: 197143341
• Report Number: 3013394970-2020-00341
• 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,foreig
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2021
• Device Model Number: N/A
• Device Catalogue Number: 610132
• Device Lot Number: 06101182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Date Manufacturer Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR