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	Fracture (1260)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Two 8f angioseal evolution devices were returned for evaluation.One device was used and another was unused.There were no anomalies noted with the unused device.For the used device,there were broken pieces of the hemostasis sheath visible on the various locations on the plastic tray.As returned, the carrier tube hub was separated from the greater length of the tube.There was slight yellow discoloration observed on the sheath.The remaining portion of the hemostasis tube was checked for maneuverability and it shattered upon application of minor force.The sheath tubing cracked in multiple locations distal to the hemostasis hub.The damage was consistent with exposure to ultraviolet light and subsequent material degradation.No other visual anomalies were noted.The angioseal evolution ifu tis-827-11232016 was reviewed and the symbols on page 10 clearly illustrate within the labeling that the device should be kept away from sunlight and uv light.The complaint is confirmed.The damage on the device was consistent with exposure of the sheath to the uv light.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with sjm specifications and procedures.A review of the device history record of the product code/lot# combination was conducted with no relevant findings.A search of the complaint file found one simialr report with the involved product code/lot# combination.The user facility reported similar events.See mdrs 2243441-2017- 00179, 2243441-2017-00180, 2243441-2017-00181, 2243441-2017-00182, and 2243441-2017-00183.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
Event or Problem Description
The user facility reported a fracture with the involved angio-seal evolution.The following information was by the user facility; (1) the sheath was opened and placed on table, but not yet introduced to patient before issue noted that caused them to quarantine.(2) saw signs of fracture in this one that i can not see from the outside of the quarantined plastic bag.(3) no patient was involved.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.There is no evidence that this event was related to a device defect or malfunction.

• 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: 6987103
• Report Number: 2243441-2017-00184
• Device Sequence Number: 13821176
• Product Code: MGB
• UDI-Device Identifier: 05415067002846
• UDI-Public: 05415067002846
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2017

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: 02/28/2018
• Device Catalogue Number: C610135
• Device Lot Number: 5904971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/05/2017
• Supplement Date Received by Manufacturer: 10/26/2017
• Initial Report FDA Received Date: 10/30/2017
• Supplement Report FDA Received Date: 11/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1