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

Catalog Number	C610135
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not implanted.The actual device has not 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 when the angio-seal device was removed from the packaging, the collagen was already visible and out of the bypass tube.A new angio-seal from the same lot number was opened and was deployed successfully.It was a complex coronary procedure.The patient was unharmed as the device did not touch the patient.No other equipment or devices were being used with the angio-seal device.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to provide the completed investigation results.One 8fr angioseal evolution device was returned for evaluation.The carrier tube assembly was received with an anchor exposed.The aluminium pouch and bypass tube was not returned.There is no indication that this event was related to a device defect or malfunction and the exact cause cannot be definitively determined.Based on the investigation results it is likely that the reported event may be related to the improper opening of the foil pouch or mishandling of the tip of the carrier tube after opening the pouch.Past complaint records have shown that if the foil pouch is not opened completely when attempting to remove the carrier tube assembly, the bypass tube can become dislodged.However, the foil pouch was not returned to confirm this.The angio-seal ifu states "remove the angio-seal device contents from the foil package by opening the package at the arrow indicator taking care to pull the foil seal apart completely before removing the angio-seal device.".
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide.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.
Event or Problem Description
Additional information was received on august 25, 2018.The patient was reported to be stable after the procedure was completed.

• 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: 7812259
• Report Number: 2243441-2018-00096
• Device Sequence Number: 1271714
• Product Code: MGB
• UDI-Device Identifier: 00389701011776
• UDI-Public: 00389701011776
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/24/2018

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: 12/31/2018
• Device Catalogue Number: C610135
• Device Lot Number: 6259184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 08/25/2018; 08/31/2018
• Initial Report FDA Received Date: 08/24/2018
• Supplement Report FDA Received Date: 08/30/2018; 09/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 84