MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION 6FR ANGIO-SEAL STS PLUS VASCULAR CLOSURE DEVICE, US; DEVICE, HEMOSTASIS, VASCULAR

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier - requested, not provided.Age & date of birth - requested, not provided.Sex - requested, not provided.Weight - requested, not provided.Ethnicity - requested, not provided.Race - requested, not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.One 6 fr angio-seal sts plus device was received for product evaluation.The hemostasis sheath, arteriotomy locator and the header bag were returned.No other components were returned.Visual inspection revealed that the locator and sheath were returned separately, not mated.There was a slight deformation observed at the blood inlet holes of the locator.No other anomalies with locator.Two kinks were found on the hemostasis sheath, one at the blood inlet holes and the other around the proximal region of the sheath.Based on the provided information and investigation results there is no 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 during insertion or presence of scar tissue could have been the cause of the kinks.However, the exact cause of the reported event cannot be definitely determined based on the available information.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 upon angio-seal insertion into the patients groin, the plastic seemed to kink and tear.Surgical or medical intervention was not required to complete the case.Additional information was received 11december2019: the procedure performed was a atherectomy arteriogram using a 6 fr sheath.The dilator seemed to be kinked.The procedure was not completed with that device, the device was not deployed due to inspection of the kinked plastic (dilator).They opened another angio-seal device.Additional information was received 12december2019: there was no harm to the patient and they left facility in stable condition.The procedure was a arteriogram.

• Brand Name: 6FR ANGIO-SEAL STS PLUS 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: 9553030
• Report Number: 3013394970-2019-01062
• Device Sequence Number: 13958058
• Product Code: MGB
• UDI-Device Identifier: 00389701011868
• UDI-Public: 00389701011868
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Report Date (Section B): 01/06/2020

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: 08/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 610119
• Device Lot Number: 06098315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1