MAUDE Adverse Event Report: UNKNOWN UNKNOWN; JAVID ARTERIAL CLAMP

Model Number	007714
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	09/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Journal article citation: argyriou, c., schoretsanitis, n., kantartzi, k., panagoutsos, s., souftas, v.D., lazarides, m.K., & georgiadis, g.S.(2019).Use of a temporary shunt to preserve the patency of a hemodialysis graft while performing ipsilateral axillo-femoral bypass.The journal of vascular access, 20(5), 553¿556.Doi: 10.1177/1129729818820205.
Event or Problem Description
It was reported in an article from the journal of vascular access titled " use of a temporary shunt to preserve the patency of a hemodialysis graft while performing ipsilateral axillo-femoral bypass " that a carotid shunt was placed in a patient with a-v graft preserving continuous ipsilateral upper arm access flow when constructing a unilateral axillo-femoral polytetrafluoroethylene bypass operation for critical limb ischemia in a hemodialysis patient.However, ultrasound imaging revealed a decrease in blood flow through the graft, probably representing a physiologic steal syndrome without clinical presentation of worsening arm ischemia.The patient was discharged home the fourth post-operative day with a patent access graft.The a-v graft continued to be used as a vascular access until 4 months later when it became thrombosed.The status of the patient was not provided.
Event or Problem Description
It was reported in an article from the journal of vascular access titled " use of a temporary shunt to preserve the patency of a hemodialysis graft while performing ipsilateral axillo-femoral bypass " that a carotid shunt was placed in a patient with a-v graft preserving continuous ipsilateral upper arm access flow when constructing a unilateral axillo-femoral polytetrafluoroethylene bypass operation for critical limb ischemia in a hemodialysis patient.However, ultrasound imaging revealed a decrease in blood flow through the graft, probably representing a physiologic steal syndrome without clinical presentation of worsening arm ischemia.The patient was discharged home the fourth post-operative day with a patent access graft.The a-v graft continued to be used as a vascular access until 4 months later when it became thrombosed.The status of the patient was not provided.
Additional Manufacturer Narrative
This supplemental mdr is being submitted to report this event is no longer mdr reportable based on new information received.

• Brand Name: UNKNOWN
• Common Device Name: JAVID ARTERIAL CLAMP
• Manufacturer (Section D): UNKNOWN; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9404471
• Report Number: 2020394-2019-05104
• Device Sequence Number: 2877316
• Product Code: DWF
• UDI-Device Identifier: 00801741090110
• UDI-Public: (01)00801741090110
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,l
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/24/2019

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 Model Number: 007714
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 12/24/2019
• 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: LOW MOLECULAR WEIGHT HEPARIN; LOW MOLECULAR WEIGHT HEPARIN
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR