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

Catalog Number	C610134
Medical Device Problem Codes	Difficult to Insert (1316); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	06/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier - requested, not provided.Age & date of birth - requested, not provided.Patient sex - requested, not provided.Weight - requested, not provided.Ethnicity - requested, not provided.Race - requested, not provided.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 resistance was met inserting the involved angio-seal device sheath.Upon removal, the sheath had a crimp in distal portion.Manual pressure was performed.The patient's condition was stable.The blood loss was less than 250cc.There was no patient injury, medical/surgical intervention required.The procedure outcome was successful.Additional information was received on 22jun2020.The procedure performed for the patient prior to use of the device was a left heart catheterization (lhc).A pre-deployment angiogram was performed.There were issues trying to insert the device sheath.
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 6fr angio-seal evolution was received for product evaluation.The arteriotomy locator was returned mated with the hemostasis sheath along with the header bag.The carrier tube assembly was returned as well.No other accessory components were returned.Visual inspection revealed that the arteriotomy locator was appropriately mated with the hemostasis sheath.Upon examination of the locator/sheath assembly, the blood inlet holes were found to be aligned and no anomalies were noted with the transition of the sheath and locator.The carrier tube was then examined under the microscope and kink was identified at the proximal portion of the manufactured slit in the carrier tube assembly.No other visual anomalies were noted.For dimension testing, the outer diameter of the carrier tube was measured to be 0.083'' which was within the specification of 0.080" +/- 0.005.The outer diameter of the sheath was measured to be 0.116'' which was within the specification of 0.114" +/-0.005".The outer diameter of the bypass tube head at the proximal end was measured to be 0.142" which was within the specification of 0.142" +/-0.005''.All measurements were within the manufacturer specifications.Ifu states: confirm that the device sleeve has remained in the rear holding position.Carefully grasp the angio-seal¿ device just behind the bypass tube with the reference indicator on the handle facing up.Support the handle as necessary to reduce likelihood of kinking.Slowly insert the bypass tube into the insertion sheath hemostatic valve.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It is likely that the attempts at device insertion using the carrier tube body or tube instead of the tip (without holding bypass tube) led to the kink which precluded further insertion; fast insertion without proper mating between the valve and bypass tube; or off-axis forces during insertion may also lead to bending or kinking of the carrier tube.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• 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
• MDR Report Key: 10258082
• Report Number: 3013394970-2020-00377
• Device Sequence Number: 17015451
• Product Code: MGB
• UDI-Device Identifier: 00389701011783
• UDI-Public: 00389701011783
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P930038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2020

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: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: C610134
• Device Lot Number: 06101378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Initial Date Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 08/12/2002
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 08/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention