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

Catalog Number	C610135
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has been received 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 sheath kinked while trying to deploy the plug, which in turn plugged the sheath.The patient's condition was stable, and the procedure outcome was a success.Additional information was received on 21aug2019.The procedure that was being performed was a peripheral angioplasty and a 7fr procedure sheath size was used.A pre-deployment angiogram was performed, and everything looked good.When the actual angio-seal was put into the angio-seal sheath, it seemed to bend and they were unable to pass anything through the sheath, not even a wire.Manual pressure was held for hemostasis.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update and to provide the completed investigation results.One 8fr angio-seal evolution device was returned for product evaluation.The evolution device and the hemostasis sheath were returned.No accessory components were returned.Visual inspection revealed that the hemostasis sheath was returned separately, and it was noted to be heavily damaged(kinked) along its length and flattened in one area.The deployment sleeve of the device was found in the forward lock position.Dried remnant of the collagen was hung at the distal end of the carrier tube and it was still intact with the suture.The bypass tube was found dislodged at the proximal end of tube.The anchor was not found attached to the collagen.The button of the device was stiff.There was a kink identified on the carrier tube.No other visual anomalies were noted 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 application of off axis forces may have contributed to the reported event.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: 8F 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
• MDR Report Key: 8971640
• Report Number: 2243441-2019-00083
• Device Sequence Number: 13535219
• Product Code: MGB
• UDI-Device Identifier: 00389701011776
• UDI-Public: 00389701011776
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2019

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: 05/31/2019
• Device Catalogue Number: C610135
• Device Lot Number: 6514903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 10/02/2019
• Initial Report FDA Received Date: 09/06/2019
• Supplement Report FDA Received Date: 10/11/2019
• 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