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

Catalog Number	610131
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.A search of the complaint file did not find any other report with the involved product code/lot# combination.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.Currently under investigation.
Event or Problem Description
The user facility reported a kink in the angio-seal device during a procedure.The following information was provided by the user facility: this was a bilateral iliac case with femoral access both on the left side; on the left side one device was kinked upon insertion and it is available to be returned for evaluation; the second device was inserted and proper deployment steps were followed, but the anchor did not set and the device failed; pressure had to be held to stop the bleeding; the physician then checked the lower leg with an ultrasound to make sure the flow had not been shut down by a loose anchor, and there was flow to the foot and a pulse was found; there was no occlusion caused by the failed device; the physician is still concerned that the anchor was in the patient; there were no issues reported for the outcome of the procedure; the blood loss was less than 250cc's; and post procedure the patient had no issues.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device evaluation.Returned in one ziploc bag was an 8fr angio-seal vip device.The carrier tube assembly was returned mated with a hemostatic sheath and had remnants of dried body fluids present.The device cap of was located in the rear lock position which is consistent with successful deployment of the device.In addition to the mated carrier tube and hemostatic sheath, an arteriotomy locator was returned mated with a third hemostatic sheath.The returned device had the anchor detached from the exposed length of the suture.There was a noted buckling at the inlet hole of the mated hemostatic sheath and arteriotomy locator.The material around the hole appeared to have been bulged.Typically, this type of deformation would have been due to the relaxation of the material around the hole when coaxial compressive forces were applied to the device.The location of the bulge was approximately 0.5530" from the distal tip of the hemostatic sheath.The dilator was removed from the hemostatic sheath and observed for any buckling; no buckling was found.There were also indentations on the distal tip of the hemostatic sheath indicating that sufficient amount of force was applied to cause deformation.Likely, this bulge developed as resistance developed concentrically around the hemostatic sheath during attempted insertion into the patient's vasculature.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to provide the completed investigation results.There is no evidence that this event was related to a device defect or malfunction.The exact cause of the reported event cannot be definitively determined based on the available information.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

• Brand Name: 8F ANGIO-SEAL VIP, US
• Common Device Name: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 2101 cottontail ln.; somerset NJ 08873
• MDR Report Key: 6682357
• Report Number: 3013394970-2017-00151
• Device Sequence Number: 16189771
• Product Code: MGB
• UDI-Device Identifier: 05415067002853
• UDI-Public: (01)05415067002853(17)171031(10)5733645
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2017

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: 10/31/2017
• Device Catalogue Number: 610131
• Device Lot Number: 5733645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/07/2017
• Supplement Date Received by Manufacturer: 07/05/2017; 09/11/2017
• Initial Report FDA Received Date: 06/30/2017
• Supplement Report FDA Received Date: 07/28/2017; 10/06/2017
• 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