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

Model Number	N/A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2021
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 the angio-seal introducer bent when attempting to put over the wire, causing them to discard and grab a new angio-seal.The patient was in stable condition.The procedure outcome was a success.There was no patient injury, medical/surgical intervention required.There were no other devices or equipment used with the reported product.Additional information was received on 05march2021: the type of procedure that was being performed was a peripheral angiogram using a french sheath.A pre-deployment angiogram was performed.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.H6: investigation findings - 3221 is based upon evaluation of the returned sample; 213 is based upon dimension testing of the returned sample.One used 6fr angio-seal evolution was received for product evaluation.The hemostasis sheath was returned mated with the arteriotomy locator.Unopened carrier tube assembly and guide wire was returned as well.Upon visual analysis, the arteriotomy locator was found to be appropriately locked with the hemostasis sheath and blood-like substances were found on the arteriotomy locator and hemostasis sheath.A slight bend was noted on hemostasis sheath.The locator/sheath assembly was examined under the microscope a kink was observed near the blood inlet holes.No anomalies were noted at the transition between arteriotomy locator and hemostasis sheath.No other visual anomalies were noted with the returned components.For dimension testing, the outer diameter of the arteriotomy locator was measured and found to be 0.090'' and which was within the specification of 0.092" +0.00/-0.02.The outer diameter of the sheath was measured to be 0.115'' which was within the specification of 0.114" +/-0.005".All measurements were within the specifications defined in the engineering drawings active at the time of manufacturing.Based on the returned device, the complaint could be confirmed for a bent in the locator, which likely happened while the user was attempting to insert the assembly into arteriotomy.The application of off-axis forces during insertion or presence of scar tissue could have been the cause of the bends or kinks.The arteriotomy locator and sheath were dimensionally and no anomalies were noted.Based on the available information, the exact cause of the issue cannot be determined.The device was in a conforming state when released from terumo control.There is no indication that any manufacturing, design, or quality system 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; 265 davidson ave; suite 320; somerset NJ 08873
• MDR Report Key: 11506228
• Report Number: 3013394970-2021-00128
• Device Sequence Number: 4088427
• Product Code: MGB
• UDI-Device Identifier: 00389701011783
• UDI-Public: 00389701011783
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2021

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: 03/13/2020
• Device Model Number: N/A
• Device Catalogue Number: C610134
• Device Lot Number: 06101907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 03/17/2021
• Supplement Report FDA Received Date: 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1