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

Model Number	N/A
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.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 or Problem Description
The user facility reported that during a lower extremity angiogram the angio-seal device did not deploy.An ultrasound was not used, and it is unsure if groin angiogram was done prior to deployment.The access side was not provided.A second angio-seal device from the same lot was used successfully.The patient was stable, and the procedure was completed.Additional information was received on 19mar2021.A 6fr procedural sheath was used.The proper steps per the ifu was taken.
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 8fr angio-seal evolution device was returned for product evaluation.The evolution body was returned partially mated with the hemostasis sheath.Locator was returned and no other accessory components were returned.Visual inspection revealed that the sheath was found to be separated the deployment sleeve of the device.The deployment sleeve was in full rear lock position and colored bands were exposed.A portion of the compaction marker was exposed (until the blue portion).The button was found to be hard.No any signs of deformation were observed on the locks of the deployment sleeve.Upon microscopic analysis, the collagen could be seen tamped at the distal end of the suture and the anchor was present adjacent to the tamped collagen.No other visual anomalies were noted.Based on the returned device, the complaint could be confirmed for the alleged failure that the user experienced as the anchor was found to be attached to the collagen upon receipt.The device was consistent with a 'pullout' of anchor and collagen scenario upon receipt.The exact cause of the alleged failure cannot be determined.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 fmea.

• Brand Name: 8F ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE, US
• Common Device Name: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 265 davidson ave; suite 320; somerset NJ 08873
• MDR Report Key: 11646721
• Report Number: 3013394970-2021-00195
• Device Sequence Number: 14186843
• Product Code: MGB
• UDI-Device Identifier: 00389701011776
• UDI-Public: 00389701011776
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2021

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: 03/31/2021
• Device Model Number: N/A
• Device Catalogue Number: C610135
• Device Lot Number: 06102537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 04/11/2021
• Supplement Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 87