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

Model Number	N/A
Medical Device Problem Code	Split (2537)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier - requested but not provided.Age & date of birth - requested but not provided.Sex - requested but not provided.Weight - requested but not provided.Ethnicity - requested, information not received.Race - requested, information not received.Implanted date: device was not implanted.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 relevant findings.
Event or Problem Description
The user facility reported that the sheath of the angio seal split upon insertion with the dilator.Patient wasn't hurt but the product was defective according to the facility.It was reported that the there was no injury to patient and that the patient condition is good.It was reported that the procedure outcome went well.Additional information was received on 11/16/17: it was reported that a second angioseal device was used in order to achieve hemostasis.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.One 8f angioseal hemostasis sheath was returned mated with the arteriotomy locator to terumo medical corporation in (b)(4).There was split observed at the tip of the hemostasis sheath, same side as the monofold.The mated device was inserted at an oblique angle into a test apparatus to check for integrity of the sheath under tension.No anomalies were noted.The outer diameter of the locator was measured to be between 0.1067"-0.1064" and the inner diameter of the sheath was measured to be 0.112".All measurements were within the manufacturing dimensions specified on the drawings active at the time of manufacturing the product.The device was subject to scanning electron microscopy and the fractured side of the split was characterized.There appeared to be unique (torn layers) morphology to the fractured face.Ftir analysis was done and the elements of the pebax and radiopaque filler materials were characterized.Energy dispersive x-ray spectra analysis for the sample did not detect any foreign elements present at various locations.Upon closer microscopic examination a faint and fine line could be seen running longitudinally upwards from the proximal cracked part of the sheath.The complaint is confirmed for a split on the distal end of the sheath same side as the monofold.Visual, microscopic, dimensional and functional evaluations were performed on the device and a thorough root cause analysis was carried out.The optical evaluation revealed longitudinal lines on the sample outer surface.These lines were presumed to be drawings marks produced during the pebax extrusion manufacturing process, that could locally weaken the sheath longitudinally and result in a split on sheath along the line when excess force is applied during mating of the locator or high off-axis forces are applied in situ.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 terumo medical corporation specifications and procedure.Similar events are being investigation through the quality system.

• Brand Name: 8F ANGIO-SEAL VIP 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: 7084314
• Report Number: 3013394970-2017-00589
• Device Sequence Number: 1297997
• Product Code: MGB
• UDI-Device Identifier: 05415067002853
• UDI-Public: 05415067002853
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P930038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2017

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: 04/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 610131
• Device Lot Number: 5992511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/09/2017
• Supplement Date Received by Manufacturer: 02/21/2018
• Initial Report FDA Received Date: 12/05/2017
• Supplement Report FDA Received Date: 02/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1