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

Catalog Number	C610134
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Operator of device: tech.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: manager.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 or Problem Description
The user facility reported that during deployment the involved angio-seal device tamp tube did not come down.Back pressure was continued.Bleeding was noticed when the suture was cut.Manual pressure was held.The patient's pedal pulses were intact.The procedure performed was a coronary percutaneous coronary intervention (pci).The patient was in stable condition pre and post surgery.There was no hematoma, however, extended manual pressure was held.The estimated blood loss was less than 250cc's.There was no direct allegation that the involved angio-seal device caused or contributed to the patient's need for medical intervention.There was no patient injury, medical/surgical intervention required.There were no other devices or equipment used with the reported product.
Additional 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 6f angio-seal evolution was returned for product evaluation.The evolution body assembly was returned mated with the hemostasis sheath along with the header bag.No other accessory components were returned.Upon visual analysis, it was noted that the carrier tube assembly was appropriately mated with the hemostasis sheath and the deployment sleeve was in the full rear lock position with the color bands fully exposed.No portion of the compaction tube was exposed or visible at the distal tip of the sheath.Neither the anchor nor collagen were returned.The button was found stiff upon receipt.Upon microscopic analysis, the compaction tube was still present within the carrier tube.No other visual anomalies were noted.Fluoroscopic analysis of the device was conducted, and the tamper tube was found to be connected to the rack and there was a noticeable kink in the sheath at distal end of the hub of sheath.No other visual anomalies were noted.For functional testing, the compaction tube was removed manually without any obstructions.The button was pressed and hold, and the suture was withdrawn by pulling manually.Suture was released as intended and no functional anomalies were noted.For further evaluation, the device was disassembled and the gearbox assembly visually inspected.The rack had been fully advanced to its distal movement stop.The suture could be seen tethered to the suture stake.No suture was present on the spool.No gross visual anomalies were observed with the gearbox assembly.The complaint could be substantiated for allegation that the tamper tube has not released.Supplier corrective action report (scar) notifications has been sent to the manufacturing facility.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 failure mode and effects analysis (fmea).

• Brand Name: 6F 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
• 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: 13686587
• Report Number: 2243441-2022-00001
• Device Sequence Number: 16611570
• Product Code: MGB
• UDI-Device Identifier: 00389701011783
• UDI-Public: 00389701011783
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: C610134
• Device Lot Number: 8176691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2022
• Supplement Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 97 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian