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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Explanted date: device was not explanted.The actual device was not 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
A patient reported that an angio-seal device was implanted in her and a year later an infection was found.The patient spent several weeks in the hospital.Additional information was received on 10/16/2018: the patient was admitted to the er on (b)(6) 2017.The procedure performed was a percutaneous coronary intervention and two stents were placed in the patients' coronary arteries.The infection then developed and the problems began about three months after the initial procedure.The patient returned to the er.The us of her heart showed a "vegetation" around the area where the stents were placed.On (b)(6) 2018 the patient was admitted to the er with an infection in her chest.The infection was in the patient's chest and had migrated to her spine.The patient stated that the infection was not in her heart and that the infection had migrated from the stents around her heart.There were no complications or signs of infection at the access site or where the angio-seal was deployed.The patient underwent surgery to her thoracic spine, had chest tubes inserted to drain the infection in her chest and had a picc line placed for long term iv antibiotic therapy.After 6 weeks, once the iv therapy was complete, she was placed on an oral antibiotic regimen.The patient was still undergoing treatment.The patient had bouts of nausea and vomiting, takes morphine three times a day, is under the care of pain management and is still on oral antibiotic therapy.The outcome of the percutaneous coronary intervention was successful.Additional information was received on 10/17/2018: the infection the patient had was a parasternal abscess.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.The evaluation of the actual device could not be conducted due to the device not being returned.With no device return, the exact cause of the reported event cannot be definitively determined based on the available information.

• 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: 7992004
• Report Number: 2243441-2018-00107
• Device Sequence Number: 1488139
• Product Code: MGB
• UDI-Device Identifier: 05415067002846
• UDI-Public: 05415067002846
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2018

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: 08/31/2017
• Device Catalogue Number: C610135
• Device Lot Number: 5648340
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/05/2018
• Supplement Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 10/22/2018
• Supplement Report FDA Received Date: 12/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOSTON SCIENTIFIC - STENT
• Patient Age: 56 YR
• Patient Weight: 68